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Merck & Co., Inc. (MRK), Clovis Oncology Inc (CLVS): All About ASCO – 2013 Highlights

Every week at The Motley Fool we reflect on the top stories in the biotech sector in a wrap-up column. This week was extraordinary, however, as we had the annual American Society of Clinical Oncology’s meeting in Chicago with dozens of biotech companies presenting early, mid-, and late-stage data, as well as preclinical abstract studies.

It would be nearly impossible and incredibly time-consuming to cover every single one; so instead, I’m going to break this week’s wrap-up into two parts: one focused entirely on ASCO, and one devoted to the going’s-on in the biotech sector beyond ASCO. Let’s begin by highlighting what appeared to be the five most important and intriguing stories to come out of ASCO this past week.

Merck & Co., Inc.Merck & Co., Inc. (NYSE:MRK)‘s Lambrolizumab, a PD-1 inhibitor that teaches that body’s own immune system to attack cancer cells, stole some of the glory away from Bristol Myers Squibb Co. (NYSE:BMY)‘s Nivolumab after it demonstrated an overall response rate of 38% in advanced melanoma. The drug already has been bestowed the rare “breakthrough therapy” designation by the Food and Drug Administration, so it could hit pharmacy shelves sooner than later if ORR data continues to prove strong.

Clovis Oncology Inc (NASDAQ:CLVS) certainly made a name for itself, more than doubling its share price, after reporting positive early stage data on CO-1686 for EGFR-mutant non-small cell lung cancer and Rucaparib for solid tumors such as ovarian cancer. Rucaparib provided an 89% clinical benefit to patients with ovarian cancer while CO-1686 indicated a partial response in three out of four patients with the T790M resistance mutation. I would still urge caution among investors, though, as these are still early studies and Clovis Oncology Inc (NASDAQ:CLVS) lost its then lead drug, CO-101, to a failed mid-stage pancreatic cancer trial in November.

Array Biopharma Inc (NASDAQ:ARRY) presented some particularly intriguing findings with its MEK inhibitor, Selumetinib, which it has licensed out to AstraZeneca plc (ADR) (NYSE:AZN) to treat uveal melanoma (cancer of the eye). Historically this is a very difficult to treat disease, but initial studies of Selumetinib more than doubled the time it took for the disease to progress compared to the current standard of treatment, Temozolomide. In trials, Selumetinib delivered 15.9 weeks without disease progression, an overall response rate of 50%, and major tumor shrinkage exhibited in 15% of patients. For Temozolomide, steady disease was only established for a median of seven weeks with no tumor shrinkage present.

Novartis AG (ADR) (NYSE:NVS)‘ LDK378, an inhibitor targeted at ALK-positive metastatic non-small-cell lung cancer patients, also wowed with its results. The inhibitor, which already has the breakthrough therapy designation, delivered an incredible overall response rate of 60% in the 78 patients tested at the 750mg dose. The most intriguing aspect of these results, beyond the incredibly high ORR, was that it worked fairly consistently whether or not patients in the study had taken Pfizer Inc. (NYSE:PFE)‘s Xalkori previously (59% ORR) or were Xalkori-naïve (62% ORR).

It wasn’t all rose petals and sunshine, though, as Synta Pharmaceuticals Corp. (NASDAQ:SNTA) was absolutely decimated after reporting its phase 2b/3 results on its second-line non-small cell lung cancer treatment Ganetespib. The results were generally positive, with the combination of Ganetespib and docetaxel improving median overall survival to 9.8 months from 7.4 months in the docetaxel-only arm. The worry among investors is that this data may not be significant enough to merit an approval by the FDA. Ganetespib’s median overall survival was more pronounced in those who were diagnosed six months or more before the study, which could lead to a selective approval there, but it would definitely limit its market potential.

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