Bristol-Myers Opdivo Positive in Phase II Study CheckMate-205

Bristol-Myers Squibb Company BMY announced an extended follow-up data on immuno-oncology drug Opdivo.

The data from ongoing phase II study CheckMate-205 evaluated adult patients with classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), irrespective of brentuximab vedotin BV therapy history.

The study evaluated objective response rates (ORR), the primary endpoint, as well as duration of response rates (DOR) for each cohort (assessed by the Independent Radiology Review Committee).

The data from the study showed that Opdivo demonstrated responses in adult patients with relapsed or progressed cHL after ASCT, irrespective of BV therapy history.

The patients had an ORR of 65%, with a complete response CR in 29% of patients, in the BV-naïve group (Cohort A: n=63). They had a median follow-up of 19 months. The median DOR was 20 months and the median progression-free survival PFS was 18.3 months.

The ORR was 68% in next group that had BV therapy after ASCT (Cohort B: n=80), with a median follow-up of 23 months. The CR was 13% in this cohort. The median DOR was 16 months and the median PFS was 14.7 months.Across cohorts, the median overall survival was not reached, and 40% of patients remained on treatment. The safety profile was consistent with the previously reported data in this tumor type.

We note that Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classic Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016).

The indication received accelerated approval based on overall response rate. The continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.

In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.

Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.

However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data. The share price of the company declined significantly on the news.

While Bristol-Myers' shares declined 6.8% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 11.4%.

Moreover, Opdivo is facing stiff competition in the U.S. With the FDA approving Merck's MRK Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.

Bristol-Myers has entered into a collaboration agreement with Seattle Genetics, Inc. SGEN to evaluate the combination of Opdivo and Seattle Genetics' antibody drug conjugate ADC Adcetris in a phase III trial as a potential treatment option for patients with relapsed/refractory or transplant-ineligible advanced cHL.

Zacks Rank & Key Pick

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

A better-ranked stock in the health care sector is VIVUS, Inc. VVUS  which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

VIVUS' loss per share estimates have narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in the four trailing quarters, with an average beat of 233.69%.

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