Bristol-Myers Reports Positive Data In NSCLC Trial On Opdivo

Bristol-Myers Squibb Company (NYSE:BMY) announced results from the phase III trial, CheckMate -078 trial on blockbuster drug Opdivo in a number of people, the majority of whom were from China.

This late-stage multinational, randomized study compared Opdivo to docetaxel in the treatment of patients with stage IIIb/IV non-small cell lung cancer (“NSCLC”) whose disease has progressed after platinum-based doublet chemotherapy.

Results showed that Opdivo demonstrated a statistically significant benefit versus docetaxel on the primary endpoint of overall survival (“OS”) as an OS benefit was observed regardless of PD-L1 expression or tumor histology. Opdivo reduced the risk of death by 32% versus chemotherapy.

Additionally, the two secondary endpoints of objective response rate and median duration of response demonstrated durability with Opdivo compared to docetaxel. Objective response rates quadrupled with Opdivo (17%) versus docetaxel (4%); median duration of response not reached with Opdivo versus 5.3 months with docetaxel.

The results will be updated in Immuno-Oncology Trials session at the American Association for Cancer Research (“AACR”) Annual Meeting 2018 in Chicago (Abstract #CT114).

We remind investors that the China Food and Drug Administration accepted the company’s Biologics License Application for Opdivo for the proposed indication of previously treated NSCLC in November 2017. A tentative approval will further boost the geographic reach of the drug.

The efficacy and safety of Opdivo in a predominantly Chinese patient population with advanced NSCLC were consistent with the results of the global CheckMate -017 and -057 studies.

Shares of the company have rallied 13.7% in the past year, outperforming the industry ’s gain of 10.6%.

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. Opdivo continues to be launched globally on approvals and label expansions. The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications including melanoma, renal cell carcinoma, and second-line NSCLC. The FDA also approved Opdivo for intravenous use for patients with hepatocellular carcinoma (“HCC”) who have been previously treated with Nexavar and Opdivo has rapidly penetrated the second line HCC market.

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

Earlier, the company stopped its phase III combination study, CheckMate-214, earlier than expected after it met its co-primary endpoint. The phase III study evaluated Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma and met its co-primary endpoint. The study showed superior OS compared to current standard of care sunitinib in intermediate- and poor-risk patients. The FDA accepted the company's sBLA for the same and will take a decision by Apr 16, 2018.

However, Opdivo faces stiff competition from Merck’s (NYSE:MRK) Keytruda and Roche’s (OTC:RHHBY) Tecentriq.

Concurrently, Bristol-Myers announced a collaboration with Illumina, Inc (NASDAQ:ILMN) to use the latter’s next-generation sequencing technology to develop and globally commercialize in-vitro diagnostic assays in support of Bristol-Myers Squibb’s oncology portfolio.

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