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Bristol-Myers (BMY) Presents Multiple Data on Opdivo at ASCO

Zacks Equity Research

Bristol-Myers Squibb Company BMY made a series of presentations at the American Society of Clinical Oncology 2019 (ASCO) annual meeting in Chicago.

The company announced encouraging updated results from studies evaluating lead immuno-oncology drug, Opdivo, and Yervoy, alone or in combination, in patients with advanced or metastatic melanoma.

With a median follow-up of 43.1 months in all patients, at four years or longer, overall survival (OS) rates were stable at 57% in a five-year analysis of the phase I CA209-004 study, the longest follow-up for the Opdivo plus Yervoy combination in patients with previously treated or untreated advanced melanoma to date.

The three-year OS rate following discontinuation of therapy was 56%. The study also showed long-term survival outcomes with Opdivo plus Yervoy, regardless of BRAF or lactate dehydrogenase (LDH) status, with four-year OS rates of 62% compared to 49% for patients with normal and elevated LDH, respectively. Data also showed four-year OS rates of 54% and 61% for patients with wild-type and mutant BRAF tumors, respectively. The overall safety of the combination was consistent with previously reported studies of these medicines in patients with advanced melanoma.

Separately, an analysis evaluating long-term quality of life (QoL) and symptom burden in the phase 3 CheckMate -067 study showed that that QoL was maintained during the treatment-free interval (TFI) in patients with previously untreated unresectable or metastatic melanoma, following discontinuation of therapy with Opdivo or the combination. 

Moreover, a four-year analysis from the CheckMate 067 study of Opdivo and Yervoy, alone or in combination, in patients with previously untreated unresectable or metastatic melanoma, showed that patient-reported QoL and symptoms were maintained from baseline during extended treatment.

The results reinforce the long-term efficacy of the combination for the treatment of advanced melanoma.

Additionally, Bristol-Myers announced first results from the Opdivo plus Yervoy cohort of the phase 1/2 CheckMate 040 study. The study is evaluating the combination in patients with advanced hepatocellular carcinoma (HCC), previously treated with Bayer’s BAYRY Nexavar. Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months.  Meaningful responses were observed across treatment arms.

Bristol-Myers’ shares have lost 11.3% in the past six months compared with the industry’s decline of 5.1%.

 

Immuno-oncology drug, Opdivo, is currently approved in several countries, including the United States, the EU and Japan for several cancer indications. Label expansion of the drug into additional indications will further boost sales. The performance of the drug has been impressive amid stiff competition from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq.

Zacks Rank

Bristol-Myers currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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