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Bristol-Myers' Combo Drugs Get FDA Nod for Colorectal Cancer

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA granted approval to the combination of its blockbuster immuno-oncology drug Opdivo (nivolumab) 3 mg/kg plus low-dose  Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.Opdivo plus Yervoy is the first immune-oncology combination therapy approved for this type of colorectal cancer. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).

The approval was based on positive data from a cohort of patients with MSI-H or dMMR mCRC, treated with the combination in the phase II CheckMate-142 study. In this cohort, 82 patients received prior treatment with fluoropyrimidine, oxaliplatin and irinotecan. Among these patients, the overall response rate (ORR) was 46%. Among the 38 responders, there were 3 complete responses (CRs) and 35 partial responses (PRs). The median duration of response (DOR) was not reached. theseThe data showed that, 89% of the responders had a response of greater than 6 months, with 21% having a response ≥12 months.

Shares of the company declined 9% year to date compared with the industry’s decline of 2.4%.

We note that Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval. It is currently approved in several countries including the United States, the EU and Japan for several cancer indications.

The Opdivo plus Yervoy combination is also approved in two other tumor types. The Opdivo (3 mg/kg) plus low-dose Yervoy (1 mg/kg) combination is approved for previously untreated patients with intermediate- or poor-risk advanced renal cell carcinoma. Opdivo (1 mg/kg) with Yervoy (3 mg/kg) is approved for patients with unresectable or metastatic melanoma under accelerated approval, based on progression-free survival. 

However, Opdivo faces stiff competition from Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, which is approved in the first-line lung cancer setting. 


Zacks Rank & Stocks to Consider

Bristol-Myers currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Ionis Pharmaceuticals, Inc. (IONS - Free Report) and ChemoCentryx, Inc. (CCXI - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Ionis’ loss per share estimates have narrowed from 13 cents to $4 cents for 2018 over the past 60 days and the earnings estimate have moved up from 5 cents to 35 cents for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 16.48%.

ChemoCentryx’s loss per share estimates have narrowed from $1.09 to 82 cents for 2018 and from $1.23 to $1.22 for 2019over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 135.3%. The stock has rallied 123.4% so far this year.

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