clovis oncology
see what the ihs markit score report has to say about clovis oncology inc .
clinical stage pipeline as of feb. 29 2016 image source: clovis oncology ,
boulder' s clovis oncology reports second quarter loss of $ 79. 4 million
clovis oncology has won approval for rucaparib in a particular population of ovarian cancer patients .
clovis oncology (clvs) up 11. 5% since earnings report: can it continue ?
why clovis oncology tumbled 13. 5% today @ themotleyfool # stocks $ clvs, $ bmy
why clovis oncology, inc. sank 28. 2% in april - - the motley fool
why clovis oncology, inc. sank 28. 2% in april @ themotleyfool # stocks $ clvs
boulder' s clovis oncology reports second quarter loss of $ 79. 4 million - boulder daily camera
new analysis published in the annals of oncology raises serious questions about the truthfulness and timing involved in the way clovis oncology ($ clvs) corrected pivotal data on its cancer drug rociletinib .
investors need to pay close attention to clovis oncology (clvs) stock based on the movements in the options market lately .
news of a collaboration with bristol - myers squibb dashed some of investor' s hopes that clovis oncology could get acquired .
patrick mahaffy, president and chief executive officer at clovis oncology in boulder. (kathryn scott osler / the denver post )
to participate in a clovis oncology clinical trial, contact the clovis oncology clinical trial navigation service at 1 - 855 - 262 - 3040 (usa) or + 1 - 303 - 625 - 5160 (ex - usa) or clovistrials @ urltoken .
clovis oncology' s (clvs) regulatory application seeking label expansion of rubraca as maintenance treatment was accepted for review in europe .
to participate in a clovis oncology clinical trial, please contact the clovis oncology clinical trial navigation service at 1 - 855 - 262 - 3040 (usa) or + 1 - 303 - 625 - 5160 (ex - usa) or clovistrials @ urltoken .
a law firm is suing clovis oncology over statements about the safety and efficacy of its now - scrapped lung cancer candidate rociletinib .
clovis oncology plans to provide an expanded description of the ariel3 results in a scientific session at a medical meeting later this year .
mutation - positive non–small cell lung cancer (nsclc), according to a statement from the drug' s developer, clovis oncology .
in july 2017, bristol - myers squibb company (bms) and clovis oncology, inc. announced the companies have entered into a clinical collaboration agreement to evaluate the combination of bristol - myers squibb’s immunotherapy nivolumab and clovis oncology’s rucaparib in pivotal phase 3 clinical trials in :
bristol - myers squibb and clovis oncology entered a clinical collaboration to evaluate the combination of nivolumab and rucaparib for treatment of three tumor types .
suresnes, november 25, 2013 – servier will be partnering with clovis oncology, an american biopharmaceutical company, for the development of lucitanib .
clovis oncology, inc. today announced that seven abstracts highlighting progress in the rubraca preclinical research and clinical development program will be presented at the 2018 american society of clinical oncology annual meeting taking place june 1 - 5 in chicago .
covering every angle of oncology practice. click a cover below, to view more .
clovis oncology presents data on its products in development at a variety of medical conferences. our current and historic presentations are provided in the following links .
sign up to receive email alerts whenever clovis oncology, inc. posts new information to the site. just enter your email address and click submit .
clovis oncology (clvs) reported earnings 30 days ago. what' s next for the stock? we take a look at earnings estimates for some clues .
clovis oncology' s (nasdaq: clvs) lucitanib has experts optimistic on phase ii breast cancer results given previously demonstrated response rates and a manageable safety profile .
immunomedics popped to an 18 - year high monday after it unveiled plans for its cancer drug, including a tie - up with clovis oncology to test a regimen .
clovis oncology, inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti - cancer agents in the u. s. , europe and additional international markets. clovis oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. clovis oncology is headquartered in boulder, colorado, and has additional offices in san francisco, california and cambridge, uk .
shares of clovis oncology inc. tanked monday after the boulder - based drug developer said the fda review and potential approval of lung cancer drug rociletinib likely will be delayed .
although a deal was what investors wanted to see, bristol - myers squibb' s willingness to partner up with clovis oncology on rubraca could someday expand rubraca' s peak sales potential .
clovis oncology, inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti - cancer agents in the u. s. , europe and additional international markets. clovis oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. clovis oncology is headquartered in boulder, colorado, and has additional offices in san francisco, california and cambridge, uk. please visit urltoken for more information .
to protect the interests of all parties, clovis will not accept unsolicited resumes from any source other than directly from a candidate. any unsolicited resumes sent to clovis, including unsolicited resumes sent to a clovis mailing address, fax machine or email address, directly to clovis employees, will be considered clovis property. clovis will not pay a fee for any placement resulting from the receipt of an unsolicited resume. clovis will consider any candidate for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees .
clovis oncology, inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti - cancer agents in the u. s. , europe and additional international markets. clovis oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. clovis oncology is headquartered in boulder, colorado, and has additional offices in san francisco, california, and cambridge, uk. please visit urltoken for more information .
clovis oncology' s (clvs) parp inhibitor, rubraca, gets its first approval in europe for the treatment of brca - mutant ovarian cancer in third - or later - line setting .
( reuters) - an independent panel of experts advising the u. s. food and drug administration recommended that clovis oncology inc’s lung cancer drug not be approved based on existing trial data .
clovis oncology, an american biopharmaceutical company announced on november 19th that it has signed a definitive agreement to acquire eos (ethical oncology science s. p. a. , a privately - held italian biopharmaceutical company from which since 2012 servier has obtained a sublicense for lucitanib rights except for japan and usa .
gritstone oncology has appointed raphaël rousseau, m. d. , ph. d. , as its cmo .
clovis oncology is facing a lawsuit over statements about the safety and efficacy of its now - scrapped lung cancer candidate rociletinib. the lawsuit stems from questions about the timing and truthfulness of statements clovis made about rociletinib results as it raced against astrazeneca to bring an egfr inhibitor to market .
clovis oncology is a biopharmaceutical company focused on acquiring, developing and commercializing cancer treatments in the united states, europe and other international markets. clovis’ development programs are targeted at specific subsets of cancer, combining precision medicine with companion diagnostics to direct therapeutics to those patients most likely to benefit from their use. clovis believes this approach to precision medicine – to deliver the right dr
- positive lung cancer ,
patrick j. mahaffy, president and ceo of clovis oncology, said in a statement. “we will continue to work diligently with the fda on our nda submission. ”
we strongly disagree with the recent editorial in the annals of oncology published on april 4. there will be an opportunity to discuss our research at a more robust and appropriate forum. clovis oncology believes in the strength of the rociletinib clinical trial program, and we look forward to upcoming discussions of our data .
new york & boulder, colo. - - (business wire) - - bristol - myers squibb company (nyse: bmy) and clovis oncology, inc. (nasdaq: clvs) announced the companies have entered into a clinical collaboration agreement to evaluate the combination of bristol - myers squibb’s immunotherapy opdivo and clovis oncology’s poly (adp - ribose) polymerase (parp) inhibitor rubraca in pivotal phase 3 clinical trials in :
you may report side effects to the fda at 1 - 800 - fda - 1088 or urltoken. you may also report side effects to clovis oncology, inc. at 1 - 844 - 258 - 7662 .
exploratory studies in other tumor types are also underway. clovis holds global rights for rucaparib .
“we are very disappointed in the outcome for rociletinib, as there is a need for additional options for this difficult to treat disease, ” patrick j. mahaffy, president and ceo of clovis oncology, in a statement .
clovis oncology (clvs) is a biopharmaceutical company with a focus on acquiring, developing, and commercializing anti - cancer agents. clovis’s rubraca (rucaparib), launched in the united states in december 2016, is approved for treating adult patients with deleterious brca1 - mutation epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received two or more chemotherapies. of the nine analysts covering clovis oncology, seven have recommended “buy” or a higher rating, while two have recommended “hold. ” clovis’s target price of $ 79. 57 implies a 67. 4% upside based on the stock’s may 24 closing price of $ 47. 52 .
the decision puts clovis behind astrazeneca, which received fda approval friday for its competing drug tagrisso .
servier will be partnering with clovis oncology, an american biopharmaceutical company, for the development of lucitanib - aktuell - servier (suisse) s. a. - coversum, preterax, fludex, diamicron, locabiotal, arcalion, daflon
clovis subsequently stopped all studies of rociletinib and switched its attention to other programs, primarily its parp drug rucaparib. but the events have dogged clovis even as it has moved on from the drug .
in the first quarter, clovis oncology’s (clvs) product revenue rose yoy (year - over - year) to $ 18. 5 million from $ 7 million. this revenue primarily consisted of us rubraca (rucaparib) sales .
the fda was expected to decide whether to approve the drug by march 30, clovis officials said .
clovis oncology, inc. today announced that patrick j. mahaffy, chief executive officer and president, will present at the goldman sachs 39th annual global healthcare conference on tuesday, june 12, 2018 at 4: 00 pm pacific time .
after getting off a $ 102 million series a, gritstone oncology has followed up with an impressive $ 92. 7 million second round .
the collaboration will include two pivotal phase 3 trials and one phase 2 trial designed to assess the pd - 1 checkpoint inhibitor nivolumab (opdivo, bristol - myers squibb) in combination with the parp inhibitor rucaparib (rubraca, clovis oncology) .
clovis chief executive patrick mahaffy said the company would work with the fda to determine the best past forward .
clovis oncology (nasdaq: clvs), whose efforts to win approval for some of its cancer - fighting drugs have been stymied by poor lab results, reported a net loss of $ 79. 4 million, or $ 2. 07 per share .
“this clinical collaboration addresses areas of unmet medical need where the combination of opdivo and rubraca may lead to an additional treatment option for patients with difficult to treat cancers, ” said fouad namouni, m. d. , head of oncology development, bristol - myers squibb. “we are committed to investigating a wide range of oncology therapies and look forward to studying the combination of clovis’ parp inhibitor and our immunotherapy. ”
at clovis oncology, we seek to support patients and caregivers by providing clear, up - to - date, accessible information about our products in development. accordingly, we provide information about ongoing clinical trials and links to other resources for cancer patients and their caregivers .
clovis oncology will head up the ovarian cancer study, while bristol - myers squibb will run the breast cancer and prostate cancer studies. it will be a bit before we know if this mash - up works, but it' s a very intriguing one - two punch .
as anticipated, the fda' s advisory committee asked clovis to come back with more data for its lead candidate .
“this clinical collaboration addresses areas of unmet medical need where the combination of opdivo and rubraca may lead to an additional treatment option for patients with difficult - to - treat cancers, ” fouad namouni, md, head of oncology development at bristol - myers squibb, said in a company - issued press release. “we are committed to investigating a wide range of oncology therapies and look forward to studying the combination of clovis’ parp inhibitor and our immunotherapy. ”
six months ago, clovis said government agencies had asked for information about the statement it released in november 2015. and now robbins arroyo is looking to round up investors affected by the crash in clovis’ stock and pursue the company in the courts .
an accelerated approval would allow clovis to conditionally market the drug, rociletinib, based on early evidence of its clinical benefit .
in our pursuit to improve the lives of people living with cancer, clovis oncology is committed to realizing the promise of precision medicine for cancer. we seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. learn more about our innovative product candidates »
clovis oncology, inc. , (nasdaq: clvs) is a biopharmaceutical company that acquires, develops, and commercializes product candidates like include rociletinib, an oral epidermal growth factor receptor and mutant - selective covalent inhibitor that is in advanced clinical development for the treatment of non - small cell lung cancer .
it' s anyone guess if clovis oncology and bristol - myers squibb' s drug trials will succeed, and there doesn' t appear to be any money changing hands between these companies. therefore, it' s understandable that m & a - hungry investors sold this company' s news today .
clovis oncology ($ clvs) today buried its controversial lung cancer drug rociletinib, ending all ongoing studies - - including the key pivotal trial - - and outlining plans to lay off 35% of its staff after the fda issued a direct message that it is prepping a formal rejection of the drug .
in the first quarter, clovis oncology’s (clvs) operating expenses rose yoy (year - over - year) to $ 100. 6 million from $ 80. 4 million, due to a larger net loss and inventories rising. clovis’s investments fell yoy to $ 9. 8 million from $ 86. 6 million due to the company buying $ 133 million in available - for - sale securities and selling $ 50 million in securities in 2017. in the first quarter of this year, clovis sold $ 10 million in available - for - sale securities and purchased $ 217, 000 in property and equipment. clovis generated $ 226. 9 million from financing activities in the first quarter of 2017 .
“we are very enthusiastic about studying rubraca and opdivo in combination, and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with brca mutations, ” said patrick j. mahaffy, president, and ceo of clovis oncology. “this substantial clinical collaboration in ovarian, triple - negative breast and prostate cancers represents a significant effort by clovis and bristol - myers squibb to realize that potential. ”
clovis has terminated enrollment in all ongoing rociletinib studies, including the phase iii tiger - 3 trial, and has withdrawn its application for regulatory approval in the european union. rociletinib will continue to be provided to patients whose clinicians recommend continuing therapy, according to clovis .
“we are very enthusiastic about studying rubraca and opdivo in combination and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with brca mutations, ” patrick j. mahaffy, president and ceo of clovis oncology, said in the release. “this substantial clinical collaboration in ovarian, triple - negative breast and prostate cancers represents a significant effort by clovis and bristol - myers squibb to realize that potential. ”
clovis oncology’s (clvs) ariel4 study on ovarian cancer is currently open for enrolment. the phase 3 multicenter randomized study is focusing on rubraca (rucaparib) in relapsed ovarian cancer patients whose cancer has advanced after two or more lines of therapy. the primary endpoint of this trial is progression - free survival. in collaboration with bristol - myers squibb, clovis is also sponsoring and conducting athena, a study on first - line maintenance treatment of advanced ovarian cancer .
“in a recent meeting with the fda, clovis was notified that it could anticipate receiving a complete response letter (crl) for the rociletinib nda on or before the pdufa date of june 28, 2016, ” the company said in its q1 statement. that will cost the jobs of 35% of the staffers and consultants who work for clovis. in february, clovis reported that it had 305 staffers on the payroll .
at recent prices, clovis oncology' s market cap is around $ 1. 41 billion, and there isn' t much in the company' s pipeline to fall back on if the fda delivers an unfavorable decision in february. bears have been emboldened to bet against the company because of a spotty past with cancer therapy response rates .
stock prices can only fall to zero, but irrational enthusiasm knows no bounds. i wouldn' t recommend shorting clovis oncology (or any biotech stocks) simply due to the lack of a ceiling on potential losses, but i wouldn' t suggest the 8. 7 million shares betting against rucaparib' s success are wrong, either .
clovis investor contacts: anna sussman, 303. 625. 5022 asussman @ urltoken or breanna burkart, 303. 625. 5023 bburkart @ urltoken or clovis media contacts: lisa guiterman, 301. 217. 9353 clovismedia @ urltoken or christy curran, 615. 414. 8668 clovismedia @ urltoken
we are a small, growing, international company, and our team is committed to realizing the potential of precision medicine in oncology – delivering the right drug to the right patient at the right time .
data from the phase ii (nct02202746) 201 patient trial is expected mid - 2016, according to analyst reports, with a likely update at the american society of clinical oncology (asco) 2016 .
clovis intends to complete a new drug application with data available from the single - arm ariel - 2 study, in the present quarter. given clovis' history of withholding less than positive clinical data, i wouldn' t put too much faith in rucaparib' s ability to save this troubled biotech .
in a communiqué released in boulder, colorado, patrick j. mahaffy, clovis oncology’s president and ceo declared: “we are pleased to expand our clinical development program to include lucitanib – it has demonstrated proof of concept in a phase i / iia study with objective responses in patients with fgf - aberrant breast cancer as well as other angiogenesis - sensitive tumors. ”
recruiting agencies must obtain advance written approval from clovis' human resources department to submit resumes, and then only in conjunction with a valid fully - executed contract for service and in response to a specific job opening. clovis will not pay a fee to any agency that does not have such agreement in place .
sticking with what is solely a matter of public record, dhingra says clovis' s timeline on reporting drug responses may not stand up under expert scrutiny .
while maintaining exclusive rights for lucitanib in the u. s. and japan, clovis intends to collaborate with servier on the global clinical development of lucitanib .
clovis oncology, inc. today announced the submission of a regulatory application to the european medicines agency, as part of a type ii variation seeking to expand the marketing authorization for rubraca to include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy... .
earlier this year, clovis oncology presented results from a study with its lead candidate, rucaparib, that highlighted troubling comparisons to a similar therapy with a head start in the ovarian cancer space. in the safety data set underpinning rucaparib' s new drug application, 59% of patients experienced side effects severe enough to interrupt dosing, and 8% discontinued treatment entirely .
boulder, colo. - - (business wire) - - jun. 11, 2018 - - clovis oncology, inc. (nasdaq: clvs) today announced that patrick j. mahaffy, chief executive officer and president, will present at the goldman sachs 39 th annual global healthcare conference on tuesday, june 12, 2018 at 4: 00 pm pacific time .
clovis ceo patrick mahaffy has kept a low profile since the controversy erupted, declining repeated requests for an interview. there’s also been considerable speculation that he could be booted from clovis in view of the rociletinib data brouhaha. there wasn' t any mention of that, though, in his call with analysts thursday evening .
boulder, colo. - - - - the filing is based on positive phase 3 ariel3 clinical trial data in which rucaparib significantly improved progression free survival compared to placebo in all primary efficacy ovarian cancer patient populations timing of validation by ema may allow for a chmp opinion on maintenance treatment by year - end 2018 clovis oncology, inc. today announced that the european medicines agency ...
the law firm' s allegations relate to differences between data clovis reported in may and november of last year. in may, clovis said a phase ii trial of rociletinib achieved an overall response rate of 60% in non - small cell lung cancer (nsclc) patients. when fda asked for more clinical data in november, clovis revealed the 60% figure was based on unconfirmed and confirmed responses. the mature data put the orr at approximately 30% , depending on the dose given .
based on the ariel3 findings, clovis oncology plans to submit a supplemental new drug application (snda) to the u. s. fda for a second line or later maintenance treatment indication in ovarian cancer by the end of october 2017. in early 2018, the company plans to file an maa in europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication .
in addition to the clovis - sponsored ariel, triton and atlas programs, the company is exploring rucaparib in combination with inhibitors of pd - 1 and pd - l1 .
rociletinib is unlikely to win u. s. approval, janney capital markets’ analyst roy buchanan told reuters, adding that he wouldn’t be surprised if clovis retracted its application .
clovis oncology, inc. (clvs) announced the first presentation of a comprehensive dataset from its phase 3 ariel3 study of rucaparib at the 2017 european society for medical oncology (esmo) congress taking place in madrid. the ariel3 study successfully achieved its primary endpoint and key secondary endpoint, demonstrating improved progression - free survival (pfs) by both investigator review and blinded independent central review (bicr) in each of the three populations studied. the data will be presented by professor jonathan a. ledermann, md, european and row principal investigator for the ariel3 study, during the proffered paper session on gynecological cancers the afternoon of friday, september 8 .
clovis’s shares tumbled as much as 18. 7 percent on tuesday. they recovered slightly to trade down 12. 5 percent at $ 13. 18 in late afternoon trading .
apparently, this development raised doubts among investors regarding the chances and the timing of drug approval, and its financial impact on clovis—the company has been burning money (see table) .
which are also developing a class of cancer drugs called parp inhibitors .
if approved, rubraca would have the broadest label of any parp inhibitor in ovarian cancer... which we think should bode well for the commercial uptake of the drug ,
schmidt said, calling the company a prime takeout candidate. in three sub - groups of women with ovarian, fallopian tube, or primary peritoneal cancer, patients on rucaparib had improved progression - free survival, the phase 3 trial' s primary endpoint. progression - free survival was also improved in patient on the drug as compared with placebo, a key secondary endpoint, clovis oncology said. the trial enrolled 564 women. clovis oncology shares have dropped 15. 9% to $ 59. 97 over the last three months, compared with a 2. 3% rise in the s & p 500
clovis oncology, inc. (clvs) announced that comprehensive data from the phase 3 ariel3 study of rucaparib for maintenance treatment of advanced ovarian cancer were published online today in the lancet. the ariel3 study successfully achieved its primary and key secondary endpoints - improved progression - free survival (pfs) by both investigator review and blinded independent central review (bicr), respectively - in each of the three populations studied, as well as its exploratory endpoints .
during the first quarter of 2016, clovis reported a net loss of $ 83. 4 million, compared to a loss of $ 63. 1 million for the first quarter of 2015 .
clovis is one of more than 100 biotech companies in the boulder valley, many of whom are also racing to prove the effectiveness of innovative cancer treatments before their investors run out of cash .
during the fourth quarter of 2016, the marketing authorization application (maa) submission in europe for rubraca in the same ovarian cancer treatment indication was submitted and accepted for review. by the end of october 2017, clovis oncology intends to submit a supplemental new drug application (snda) in the u. s. for a second line or later maintenance treatment indication in ovarian cancer based on the ariel3 data, and in early 2018, plans to file an maa in europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication. studies open for enrollment or under consideration include ovarian, prostate, breast, pancreatic, gastroesophageal, bladder, lung, and urothelial cancers. clovis is also developing rubraca in patients with mutant brca tumors and other dna repair deficiencies beyond brca – commonly referred to as homologous recombination deficiencies, or hrd. clovis holds worldwide rights for rubraca .
“the publication of the ariel3 data in this prestigious, peer - review journal reinforces the importance of identifying new therapies that provide meaningful clinical benefit to women with advanced ovarian cancer, and speaks to the high quality of the study design and the data we were able to deliver, ” said patrick j. mahaffy, president and ceo of clovis oncology. “we extend our sincere thanks to the study investigators and authors, as well as the many patients, who supported and participated in ariel3. ”
we are focused on developing targeted therapies in pursuit of meaningful improvements in the lives of patients with cancer. we welcome you to learn more about clovis, and the opportunities available to be part of our team .
under the agreement, clovis will be the study sponsor and conducting party for the study in ovarian cancer. bristol - myers squibb will be the study sponsor and conducting party for the breast cancer and prostate cancer studies .
at bristol - myers squibb, patients are at the center of everything we do. our vision for the future of cancer care is focused on researching and developing transformational immuno - oncology (i - o) medicines for hard - to - treat cancers that could potentially improve outcomes for these patients .
dhingra is a longtime drug developer, with stints at eli lilly ($ lly) as well as roche. he currently is the principal officer at kapital consulting and sits on the board at advanced accelerator applications, five prime, exosome diagnostics and autolus. dhingra held the same position at micromet and biovex, both bought out by amgen in deals worth up to $ 2. 6 billion. he is also an associate editor at the annals of oncology, though he wrote the piece on clovis as an individual expert observer .
clovis ceo patrick mahaffy did not respond immediately to a query from fiercebiotech this morning. after the market closed on monday, with the stock down 11% for the day, the company sent a statement to me saying :
dr emmanuel canet, head of research and development at servier, declared that clovis’ decision to acquire eos and pursue the development of lucitanib was a great opportunity, leading the way for a strong global clinical evaluation for lucitanib .
clovis says that the radical change - up was due to an unexpected, eleventh - hour erosion in the data, as the unconfirmed responses tracked in the interim data failed to pan out in the final analysis as confirmed responses .
clovis oncology, inc. (clvs) today announced that the european commission (ec) has authorized rubraca (rucaparib) as monotherapy treatment of adult patients with platinum - sensitive, relapsed or progressive, brca mutated (germline and / or somatic), high - grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. certain confirmatory post - marketing commitments are required as part of this conditional authorization .
clovis’ stock lost more than two - thirds of its value after the company announced that the u. s. food and drug administration sought additional clinical data for rociletinib, a targeted oral treatment for non - small - cell lung cancer .
perhaps in anticipation of a rociletinib' s imminent doom, clovis recently began a rolling submission of its second - most developed compound. once again, astrazeneca already has a similar drug on pharmacy shelves, lynparza, for the same patient population .
clovis shares closed monday afternoon at $ 15. 69, down 9. 88 percent from the previous day' s close of $ 17. 41. the stock' s 52 - week price range is $ 11. 57 to $ 116. 75 .
once a closely watched rival to a similar drug from astrazeneca ($ azn), clovis’s roci team was pummeled during a recent panel review of its accelerated approval application for the egfr inhibitor. the outside experts voted 12 to 1 to force clovis to finish a late - stage study before it could look at another application. but today the biotech says that study - - tiger - 3 - - will be shuttered along with all other clinical programs for the drug. and the company is withdrawing its european application for roci .
fibroblast growth factors (fgfs) and vegfs each play a role in tumor growth and angiogenesis and both are validated targets in oncology. lucitanib is unique in its pattern of clinical inhibition of both fgfr and vegfr tyrosine kinases. lucitanib has the potential of providing benefit to cancer patients by targeting two relevant tumor growth factors in targeted patient populations identified by molecular markers .
bristol - myers squibb media: lisa mccormick lavery, 609 - 252 - 7602 lisa. mccormicklavery @ urltoken or ken dominski, 609 - 252 - 5251 ken. dominski @ urltoken or investors: tim power, 609 - 252 - 7509 timothy. power @ urltoken or bill szablewski, 609 - 252 - 5894 william. szablewski @ urltoken or clovis oncology investors: anna sussman, 303 - 625 - 5022 asussman @ urltoken or breanna burkart, 303 - 625 - 5023 bburkart @ urltoken or media: lisa guiterman, 301 - 217 - 9353 clovismedia @ urltoken or christy curran, 615 - 414 - 8668 clovismedia @ urltoken
as an ongoing trial, some of the datasets submitted to the fda contained immature findings, specifically for unconfirmed and confirmed response rates. at a preplanned 90 - day meeting with the fda, clovis provided updated response rates, initiating the call for a more thorough review .
in this era of rapidly evolving science and breakthrough medicines, we are all rushing full speed ahead to get important medicines to patients quickly ,
dhingra sums up .
the story of rociletinib should serve as a reminder that sometimes' haste makes waste'. this author has forcefully argued for acceleration of targeted oncology drugs based on relatively small datasets from early clinical trials. such a thoughtful acceleration of drug development is possible in a variety of ways but it requires a vigilant attitude toward emerging data and quick course corrections in the event new data are not consistent with the initial observations. these lessons will become increasing important especially as we move deeper and further into the emerging world of novel therapies, especially immuno - oncology and cellular therapies .
the drug developer’s stock plunged 70 percent, or $ 69. 19, to $ 30. 24 monday, its biggest ever one - day drop. clovis shares had climbed nearly 78 percent so far this year, as of friday, after closing 2014 at $ 56 .
none of the (company' s) three press releases disclosed as to what proportion of responses, if any, were confirmed responses according to the usual and customary definition of response ,
he writes .
it is worth emphasizing that the asco presentation was only about two months before the completion of the company' s nda filing. importantly, majority of the patients in the tiger - x trial had been enrolled in 2014 or earlier (clovis oncology asco 2015 investors' event). this raises a very distinct possibility that by asco 2015, the data from the tiger - x trial were relatively mature with respect to confirmation of responses .
“we remain confident in rociletinib and its potential to treat patients with mutant egfr t790m - positive lung cancer, ” clovis president and ceo patrick j. mahaffy said in a statement. “we will continue to work diligently with the fda on our (new drug application) submission. ”
urltoken is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. information on trials run by clovis, our development partners, or by independent investigators can be accessed on urltoken by using the “search for studies” function and entering “rucaparib. ”
about servier servier is a privately - run french research - based pharmaceutical company. current therapeutic domains for servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. servier is established in 140 countries worldwide with over 20, 000 employees and a 2012 turnover of €3. 9 billion. servier invests 25% of its turnover in r & d .
) - - clovis oncology, inc. (nasdaq: clvs) today announced topline data from the confirmatory phase 3 ariel3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression - free survival (pfs) by investigator review in each of the three populations studied. pfs was also improved in the rucaparib group compared with placebo by blinded independent central review (bicr), a key secondary endpoint. based on these findings, the company plans to submit a supplemental new drug application (snda) within the next four months for a second - line and later maintenance treatment indication for all women with platinum - sensitive ovarian cancer who have responded to their most recent platinum therapy .
“we are very pleased with these positive ariel3 topline results that strongly demonstrate the potential of rucaparib to help women with platinum - sensitive, advanced ovarian cancer, ” said patrick j. mahaffy, president and ceo of clovis oncology. “these results reinforce the potentially foundational role of rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review. most importantly, we are grateful to the patients, caregivers and investigators who participated in this study. we look forward to sharing these data in greater detail at a medical meeting later this year and submitting our snda as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer. ”
luckily, this time it looks like clovis' drug still has a chance. even after approving lynparza, the fda gave rucaparib a breakthrough therapy designation, this designation is reserved for drugs that show strong potential to provide better outcomes over existing therapies, and it is intended to expedite the regulatory process .
the shock sank clovis’ stock, tarnished its reputation and left it with an uphill battle to show how rociletinib could compete with astrazeneca’s tagrisso. astrazeneca won approval for tagrisso at around the same time as the reevaluation of rociletinib’s orr. and it did so on the back of chalking up a 59% orr .
the fda’s approval of clovis oncology’s (clvs) rubraca (rucaparib) for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in april was the second and much broader indication the drug has been approved for. unlike for its first indication, diagnostic testing is not required for patients to be prescribed rubraca for this maintenance indication. in march, the ema’s (european medicines agency) committee for medicinal products gave a positive opinion on granting conditional marketing authorization for rubraca as a monotherapy for adult patients with relapsed and platinum - sensitive brca1 - mutated high - grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received two or more platinum - based chemotherapies and are unable to tolerate more .
if the fda asks for more data in february, or simply delays its decision, investors betting against clovis would come out ahead. even if rucaparib earns approval, an unsuccessful launch in the face of competition from astrazeneca' s entrenched drug of the same class could also lead to losses in the longer term .
instead clovis finally decided to cut its losses and announced it would terminate ongoing rociletinib studies, and it also withdrew its eu application. by the end of the year it intends to reduce staff and contractor positions by more than one - third in order to funnel all available resources into what remains of its pipeline .
during an interview with me, dhingra underscored his concerns that clovis' s actions could raise questions - - and regulatory fears - - about all accelerated development efforts in the cancer field. and that could blight other biotech' s chances to pursue the kind of fast - paced development schedules that have become the norm .
according to the updated data from clovis, evaluable patients treated with the 500 mg dose of rociletinib (n = 79), experienced a confirmed response rate of 28% . in 170 patients treated with the 625 mg dose, the confirmed response rate was 34% . the duration of response for both doses was 9 months .
the author - - who emphasized that he has no business relationship with either astrazeneca or clovis - - adds that he followed the tale of the t790 egfr inhibitors as a
great example of targeted and personalized medicine, sort of the can' t - miss drugs. of course, the reality has played out quite differently .
in july 2014, opdivo was the first pd - 1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. opdivo is currently approved in more than 60 countries, including the united states, the european union, and japan. in october 2015, the company’s opdivo and yervoy combination regimen was the first immuno - oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the united states and the european union .
clovis stock shot up after the food and drug administration (fda) agreed to continue the review of rucaparib without calling together an independent advisory committee meeting. the fda typically holds such meetings when a new drug candidate' s risk - to - benefit profile is questionable. many view its willingness to go ahead without calling together a committee as a bullish signal .
robbins arroyo is behind the lawsuit. the law firm is alleging clovis made “false, incomplete, and misleading statements” about the safety and efficacy of rociletinib. lawsuits against publicly traded biotechs are a common occurrence. but few are based on events quite as damaging to a biotech and its reputation as the series of revelation that led to robbins arroyo filing its case .
in december 2016, rubraca ® became the first parp inhibitor approved by the u. s. food and drug administration (fda) as monotherapy for treatment of patients with deleterious brca mutation (germline and / or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. during the fourth quarter of 2016, a marketing authorization application (maa) was submitted and accepted in europe for rubraca in the same ovarian cancer - treatment indication. based on the ariel3 findings, clovis oncology plans to submit a supplemental new drug application (snda) to the u. s. fda for a second line or later maintenance treatment indication in ovarian cancer by the end of october 2017, and in early 2018, plans to file an maa in europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication .
boulder, co - based clovis, though, was allowed to publish the suspect data in the prestigious new england journal of medicine, making a high - profile case that the biotech had to recant later. and would the nejm have even accepted the study for publication, dhingra asks, if the response rates were as low as they eventually turned out to be ?
that earned approval in 2014. although the two drugs weren' t compared in a head - to - head trial, lynparza appears slightly more tolerable than the clovis candidate. in a study with 223 patients that had received three or more lines of chemotherapy, 40% treated with lynparza suffered side effects severe enough to interrupt dosing, and 7% discontinued treatment altogether .
in the journal article, dhingra takes issue with the way in which clovis executives and their investigators reported the data, saying that they failed to highlight the distinction between unconfirmed and confirmed responses according to clear, well established industry trial standards, touting promising outcomes even when the data should have been sufficiently advanced to alert the company to the truth long before the big reveal .
in addition to tiger - x, data for rociletinib were submitted from the single - arm phase ii tiger - 2 trial, according to clovis. in this ongoing study, rociletinib is being explored as a second - line therapy in patients with egfr t790m - mutated nsclc. data from this study have not yet been announced, with the first patient enrolled in june 2014 .
if the on - going phase ii monotherapy studies for lucitanib are successfully completed, clovis and servier intend to pursue future development of lucitanib as monotherapy and / or in combination with estrogen antagonists in treatment - refractory breast cancer. other potential indications that may be considered for development include squamous nsclc, bladder, head and neck cancer, and other solid tumors with fgf - aberrancies .
opdivo’s leading global development program is based on bristol - myers squibb’s scientific expertise in the field of immuno - oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumor types. to date, the opdivo clinical development program has enrolled more than 25, 000 patients. the opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from opdivo across the continuum of pd - l1 expression .
rucaparib is an oral, small molecule inhibitor of parp1, parp2 and parp3 being developed in ovarian cancer as well as several additional solid tumor indications. in december 2016, rucaparib became the first parp inhibitor approved by the u. s. food and drug administration (fda) as monotherapy for treatment of patients with deleterious brca mutation (germline and / or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. studies open for enrollment or under consideration include ovarian, prostate, breast, pancreatic, gastroesophageal, bladder, lung and urothelial cancers. clovis is also developing rucaparib in patients with mutant brca tumors and other dna repair deficiencies beyond brca – commonly referred to as homologous recombination deficiencies, or hrd. clovis holds worldwide rights for rucaparib .
late last year, the market pummeled clovis shares when it had to update overall response rates for lung cancer hopeful rociletinib from 53% to between 28% and 34% . the admission after submitting its new drug application cast a shadow on management' s level of transparency. the fda later asked for more data before considering the application, and the company switched gears to focus on rucaparib .
the lower final response rate may make the drug uncompetitive against astrazeneca' s therapy, but that wouldn' t necessarily prevent the fda or its advisory group from endorsing the drug for marketing. for several years now the fda' s oncology advisory group has been very receptive to any therapies that can add another arrow to an oncologist' s quiver in the fight to delay cancer. and while lower response rates may be less appealing, the data suggest the drug is having an impact, which would normally be enough for an approval .
clovis planned to submit the requested data for the 500 - mg and 625 - mg doses of rociletinib to the fda on november 16, 2015, according to the company. the request for additional data is likely to delay a regulatory decision on the medication by 90 days. prior to this development, the fda had granted rociletinib a priority review and an action date of march 30, 2016 .
clovis has a robust clinical development program underway in multiple tumor types, including metastatic castration - resistant prostate and bladder cancers. rucaparib is in clinical development for the treatment of metastatic castration - resistant prostate cancer patients in the triton2 trial for patients with brca mutations and atm mutations or other deleterious mutations in other hr repair genes and the triton3 trial for patients with brca mutations and atm mutations who have progressed on ar - targeted therapy and who have not yet received chemo in the castrate - resistant setting. both trials are open for enrollment. clovis is also sponsoring a phase 2 open - label monotherapy study of rucaparib in recurrent, metastatic bladder cancer titled atlas: a study of rucaparib in patients with locally advanced or metastatic bladder cancer. this study will open for enrollment during the first half of 2018 .
“i first dosed a patient with rucaparib over five years ago, and these robust and exciting data are consistent with my experience, ” said professor jonathan ledermann, professor of medical oncology, director, cancer research uk and ucl cancer trials centre, ucl cancer institute, and european and row principal investigator for the ariel3 study. “these results show that rucaparib has the potential to provide an enduring and important clinical benefit in women with advanced ovarian cancer, irrespective of their tumor genetics. this is a very important step forward for women with advanced ovarian cancer. ”
clovis will hold a conference call to discuss the ariel3 results this morning, june 19, at 8: 30am et. the conference call will be simultaneously webcast on the company’s web site at urltoken, and archived for future review. dial - in numbers for the conference call are as follows: u. s. participants 866. 489. 9022, international participants 678. 509. 7575, conference id: 42436102 .
the planned multi - arm clinical trials will be conducted in the u. s. , europe, and possibly additional countries. clovis will be the study sponsor and conducting party for the ovarian cancer study and bristol - myers squibb will be the study sponsor and conducting party for the breast and prostate cancer studies. specific terms of the agreement were not disclosed. all three studies are expected to begin before the end of 2017.
clovis oncology is a mid-sized pharmaceutical company which mainly markets products for treatment in oncology . clovis was founded in 2009 and is headquartered in boulder , colorado . the company is a publicly traded company on nasdaq under the symbol " clvs " and is in the nasdaq biotechnology index with several products in its product pipeline . 
clovis oncology is a mid-sized pharmaceutical company which mainly markets products for treatment in oncology. clovis was founded in 2009 and is headquartered in boulder, colorado. the company is a publicly traded company on nasdaq under the symbol " clvs " and is in the nasdaq biotechnology index with several products in its product pipeline.
clovis oncology is a mid-sized pharmaceutical company which mainly markets products for treatment in oncology. clovis was founded in 2009 and is headquartered in boulder, colorado. the company is a publicly traded company on nasdaq under the symbol " clvs " and is in the nasdaq biotechnology index with several products in its product pipeline.