Bristol-Myers Squibb Company (BMY - Free Report) announced encouraging data from the phase III CheckMate -214 study on Opdivo.
CheckMate-214 study is an ongoing study evaluating Immuno-Oncology combination Opdivo (nivolumab) and low-dose (1mg/kg) Yervoy (ipilimumab) compared with Pfizer’s (PFE - Free Report) Sutent (sunitinib) in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) over a two-year follow-up period. The treatment with Opdivo plus low-dose Yervoy led to statistically significant differences in patient-reported outcomes from baseline versus sunitinib through two years of follow-up. The study demonstrated that patients showed significant benefits in disease-related symptoms and improvements to their cancer-related quality of life and well-being.
These benefits occurred early during Opdivo plus low-dose Yervoy combination therapy and were largely maintained throughout the treatment period and through Opdivo maintenance therapy.
The CheckMate-214 study for patients with advanced renal cell carcinoma had earlier shown efficacy benefit of Opdivo plus low-dose Yervoy across a number of measures, including overall survival, objective response rate and progression-free survival. However, the results presented now showed that patients treated with this Immuno-Oncology combination also reported significant improvements in disease-related symptoms, as well as positive changes to their physical, emotional and functional well-being.
An additional analysis showed similar results with a significant benefit seen for Opdivo plus low-dose Yervoy relative to sunitinib on change from baseline at a pre-planned 25-week landmark.
Bristol-Myers’ shares have declined 16% year to date compared with the industry’s decline of 4.4%.
We note that, Opdivo, became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries including the United States, the EU and Japan for several cancer indications. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma in both the United States (May 2016) and the EU (November 2016).
In November 2016, Opdivo gained 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.
Meanwhile, the company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the drug into additional indications would give the product an access to a higher patient population and increase its commercial potential significantly.
However, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC), the company is expected to suffer further loss of market share.
In a separate release, Bristol-Myers announced that the FDA lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a phase III study evaluating the addition of Opdivo to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision follows consultation with the FDA and agreement on amendments to the study protocol.
The FDA put clinical hold on three studies evaluating Opdivo-based combinations in relapsed or refractory multiple myeloma in September 2017 as an FDA precaution following risks identified in trials studying another anti–PD-1 agent, Keytruda, in patients with multiple myeloma.
Stocks That Warrant a Look
Bristol-Myers carries a Zacks Rank #3 (Hold).
A better-ranked stock from the same space is Illumina, Inc. (ILMN - Free Report) , sporting a Zacks Rank#1 (Strong Buy),.You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings per share estimates have moved up from $4.83 to $4.86 for 2018 and from $5.57 to $5.60 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has rallied 28.2% so far this year.
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