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March 27, 2014
05:48 EDTCLVSClovis CO-1686 shows compelling clinical activity, PFS in updated Phase 1 study
Clovis Oncology announced updated findings from the Phase 1 portion of its ongoing Phase 1/2 clinical study of CO-1686, the company’s novel, oral, targeted covalent inhibitor of mutant forms of the epidermal growth factor receptor, or EGFR, for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. In the 22 evaluable T790M positive patients across efficacious dose levels, 14 RECIST partial responses, or PRs, have been observed to date, for a 64% objective response rate, or ORR. Ten of the 14 patients started CO-1686 therapy immediately following progression on a prior TKI. Twenty of the 22 evaluable T790M positive patients, or 91%, have experienced stable disease or a PR. The median duration of response cannot yet be estimated in the T790M positive patients. However, progression-free survival, or PFS, greater than six months has been observed in evaluable T790M positive heavily-pretreated patients and the median has not yet been reached. In contrast, PFS in T790M negative patients is shorter, with a median of three months. CO-1686 is well-tolerated, with only one patient who discontinued treatment with CO-1686 due to adverse events. There was no evidence of systemic wild-type EGFR inhibition. The most common adverse events were hyperglycemia, nausea, diarrhea, decreased appetite and vomiting, and these were mostly grade 1 in severity. The most common grade 3 adverse event was hyperglycemia, which was observed in 19% of patients. Hyperglycemia, when observed and requiring treatment, is typically asymptomatic and managed with a commonly prescribed single oral agent.
News For CLVS From The Last 14 Days
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July 2, 2015
10:38 EDTCLVSFly Watch: Biotech sector events to watch for this summer
Three key events in the biotech sector are slated to occur this summer, Mizuho Securities previewed in a note to investors today. Namely, data from Clovis Oncology's (CLVS) lung cancer treatment is expected to be released, interim data for Verastem's (VSTM) cancer treatment could be unveiled and the PDUFA date for Tesaro's (TSO) rolapitant drug for chemotherapy-induced nausea and vomiting will occur. A PDUFA date is the day on which the FDA is expected to decide whether to approve a drug. WHAT'S NEW: Data for Clovis' rociletinib lung cancer treatment is expected by the firm to be released September 6-9, Mizuho analyst Peter Lawson wrote. Favorable data could result in the the drug more quickly becoming the first treatment option after it hits the market, the analyst stated. Interim data for Verastem's cancer treatment product, defactinib, will have one of three outcomes, Lawson forecast: additional patients will be enrolled in the study, the study will be terminated due to poor results or the patients in the study with low levels of a tumor suppressor gene product called Merlin will be enriched for Merlin. According to Lawson, expectations heading into the trial are low, and the most likely outcome is that the Merlin enrichment scenario will occur. If this scenario does occur, Verastem's stock will probably temporarily fall, potentially creating a better entry point, Lawson believes. The PDUFA date for Tesaro's rolapitant drug is September 5, the analyst stated. The analyst kept a $103 price target and Buy rating on Clovis, a $67 price target and Buy rating on Tesaro and a $21 price target and Buy rating on Verastem. PRICE ACTION In early trading, Clovis fell 2.2% to $83.98, Verastem retreated 2.3% to $6.96 and Tesaro dropped 1.7% to $55.80.
July 1, 2015
16:07 EDTCLVSClovis initiates rolling NDA submission to FDA for Rociletinib
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June 22, 2015
08:03 EDTCLVSClovis names Dr. Lindsey Rolfe as Chief Medical Officer
Clovis Oncology announced that Dr. Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, has been named Chief Medical Officer and EVP of Clinical and Preclinical Development and Pharmacovigilance, to become effective in early August. Dr. Rolfe succeeds Dr. Andrew Allen, who will be stepping down from his role at Clovis at that time to create a new immuno-oncology focused biotechnology company and serve as its CEO. Dr. Rolfe joined Clovis in early 2010 and oversees rociletinib and rucaparib development in her current role as SVP of Clinical Development. As Chief Medical Officer at Clovis, Dr. Rolfe will be responsible for clinical development, preclinical development, clinical operations and pharmacovigilance and will also serve on the company’s executive committee.

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