Clovis Oncology Trying To Rebuild A Once-Bright Outlook
Stephen Simpson, CFA
Stephen Simpson, CFA
Clovis Oncology: Derisked Takeout Story
Poonam A. Arora • 19 Comments
Poonam A. Arora • 19 Comments
Tue, Aug. 23, 5:35 PM
Tue, Aug. 23, 3:52 PM
- Battered and bruised Clovis Oncology (CLVS +31%) recaptures some its former glory on the news that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and who have been treated with least two chemo regimens.
- The NDA has Priority Review status which shortens the review clock to six months from the usual 10 months. The agency's action date (PDUFA) is February 23, 2017.
- In two late-stage studies, the overall objective response rate for rucaparib-treated ovarian cancer patients was 54% (n=57/106).
- Rucaparib is a small molecule poly ADP-ribose polymerase (PARP) inhibitor that specifically binds to PARP-1 and PARP-2. PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
- Clovis had lost ~90% of its value since late 2015 when it stumbled with rociletinib. Shares have rebounded of late. They are up more than 113% since bottoming at $11.57 on June 27.
- PARP inhibitor competitor TESARO (TSRO -5.9%) slumps on the news.
Wed, Jun. 29, 12:46 PM
Wed, Jun. 29, 11:10 AM
Wed, Jun. 29, 9:24 AM
- Clovis Oncology (NASDAQ:CLVS) is up 17% premarket on robust volume in a ripple effect from the bullish action in TESARO (NASDAQ:TSRO) following its announcement of positive late-stage result for PARP inhibitor niraparib.
- Clovis' Phase 2-stage rucaparib is also a PARP inhibitor.
- PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
- Previously: TESARO's niraparib successful in late-stage ovarian cancer study clearing the way for regulatory submission in Q4; shares ahead 69% premarket (June 29)
Wed, Jun. 29, 9:16 AM
Wed, Apr. 13, 12:47 PM
Tue, Apr. 12, 3:26 PM
- The FDA's Oncologic Drugs Advisory Committee votes 12-1 against accelerated approval of Clovis Oncology's (CLVS -11.8%) rociletinib for the treatment of EGFR-positive non-small lung cancer. The panel requires additional Phase 3 data to support its application.
- Results from TIGER-1 should be available in a couple of months. The FDA's action date (PDUFA) is June 28.
- If the FDA insists on data from the TIGER-3 study, results won't be available until 2019.
- Update: In a statement, Clovis confirms that the FDA wants to see the results from TIGER-3 before deciding on approval. Shares have resumed trading and are down on almost triple normal volume.
Tue, Apr. 12, 7:16 AM
- As usual with an Ad Comm review, trading in Clovis Oncology (NASDAQ:CLVS) is on hold pending the outcome of today's meeting of the FDA's Oncologic Drugs Advisory Committee during which it will discuss the company's New Drug Application (NDA) seeking approval of rociletinib for the treatment of EGFR-positive non-small cell lung cancer.
Fri, Apr. 8, 5:40 PM
Fri, Apr. 8, 9:10 AM
- The FDA's Oncologic Drugs Advisory Committee will meet on Tuesday, April 12 to discuss Clovis Oncology's (NASDAQ:CLVS) New Drug Application (NDA) seeking approval of rociletinib for the treatment of patients with epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC).
- Based on the FDA's briefing document, a positive vote is far from certain. For example, the objective response rate (ORR), based on pooled data for the 500 mg, 625 mg and 750 mg dosage arms, was 30%, far short of AstraZeneca's (NYSE:AZN) Tagrisso (osimertinib) which showed a 59% ORR in clinical studies. Also, rociletinib's safety profile is concerning. In a pooled analysis, the most common adverse events were diarrhea (55%), nausea (52%), hyperglycemia (58%) and fatigue (44%). Serious adverse events (grade 3 or higher) were reported in 44% of patients receiving the 500 mg dose. 51% of patients (all dosages) had one or more dose reductions due to adverse events (40% of the 500 mg cohort). The incidence of adverse events in clinical studies for Tagrisso was no more than 25% for most (diarrhea: 42%, rash: 41%, dry skin: 31%).
- Investors appear unconcerned. Shares are up 2% premarket on robust volume.
- FDA briefing doc
- Errata to FDA briefing doc
- Company briefing doc
Mon, Apr. 4, 5:09 PM
- Clovis Oncology (NASDAQ:CLVS) had a rough day today as shares fell 11% on more than double normal volume. There appears to be a growing lack of confidence that the company's Breakthrough Therapy-tagged lung cancer candidate, rociletinib, will get a "thumbs up" at next week's Ad Comm meeting (Tuesday, April 12). The noise continues to build that the company has been less than forthright with the data from the Phase 3 study so there will be substantial scrutiny on the briefing docs that will be released no later (hopefully) than Friday, April 8.
- Shares plummeted last November when the company announced that the FDA requested additional efficacy data on both the 500 mg and 625 mg dosage groups. It also disclosed that the confirmed response rates were about 20 percentage points lower than expected (28% for 500 mg and 34% for 625 mg). So low, in fact, that its effectiveness appears to be well below rival AstraZeneca's (NYSE:AZN) Tagrisso (osimertinib), which showed an overall response rate of 59% in clinical studies. One industry expert, Kapil Dhingra, believes the company knew the confirmed response rates at the time of the ASCO presentations, two months before its NDA filing was completed, but failed to disclose the information to the market.
- The FDA's action date (PDUFA) is June 28. It was originally March 30 before the agency requested the additional data.
- Shares have lost ~85% of their value since mid-September.
- Now read Clovis Oncology Trying To Rebuild A Once-Bright Outlook
Nov. 27, 2015, 9:19 AM
Nov. 17, 2015, 9:16 AM
Nov. 16, 2015, 12:45 PM
Nov. 16, 2015, 9:17 AM
- Clovis Oncology (NASDAQ:CLVS) gets smacked down 71% premarket on robust volume in response to its announcement that the confirmed response rate in its ongoing clinical studies of Breakthrough Therapy-tagged rociletinib in EGFR T790M+ lung cancer is lower than expected and the FDA has requested additional efficacy data on both the 500 mg and 625 mg dosage groups. The agency's time clock to review the data, expected to be submitted today, will delay regulatory approval (the PDUFA date is currently March 30).
- In a Mid-Cycle Communication meeting with the FDA held last week, the review team emphasized that it will focus exclusively on confirmed responses for its efficacy analysis. As the rociletinib trials progressed, the data set included mostly unconfirmed responses. In its NDA submission, accepted for review by the FDA in September, the data included both immature confirmed and unconfirmed response analyses. As the efficacy data has matured, the number of patients with an unconfirmed response who converted to a confirmed response has been lower than expected. The current confirmed response rates for the 500 mg and 625 mg cohorts are 28% and 34%, respectively. The most frequent reasons for the lack of confirmation in a subsequent scan were progression and failure to show tumor shrinkage greater than 30%.
- Rociletinib (CO-1686) is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR).
- Previously: Clovis reports double dose of good news regarding regulatory status of rociletinib (Sept. 29)
- Previously: Clovis completes NDA submission for rociletinib for second line treatment of lung cancer (Aug. 3)
Clovis Oncology, Inc. is a biopharmaceutical company which focuses on acquiring, developing and commercializing cancer treatments in the United States, Europe and other international markets. The company has three product candidates in its clinical development pipeline: Rociletinib, Rucaparib... More
Country: United States