Bristol Myers pulls FDA application for Opdivo combination in lung cancer

Opdivo, Bristol’s most important growth driver, has lost much of its lustre as Merck & Co’s rival drug Keytruda seized dominance in advanced lung cancer, the most lucrative oncology market. Wall Street tends to view any setback for Opdivo as positive news for Keytruda.

NEW YORK: Bristol-Myers Squibb Co on Thursday said it withdrew its application seeking U.S. approval for a combination of its blockbuster cancer immunotherapy drugs Opdivo and Yervoy as an initial treatment for advanced lung cancer while the drugmaker works to collect more data.

The company, which announced a planned $74 billion acquisition of biotech Celgene Corp earlier this month, also posted a higher-than-expected fourth-quarter profit, and forecast 2019 earnings roughly in line with Wall Street expectations.

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Opdivo, Bristol’s most important growth driver, has lost much of its lustre as Merck & Co’s rival drug Keytruda seized dominance in advanced lung cancer, the most lucrative oncology market. Wall Street tends to view any setback for Opdivo as positive news for Keytruda.

Opdivo, which is approved to treat several types of cancer, continues to do well, however. Fourth-quarter sales of $1.8 billion easily exceeded analysts’ estimates of $1.47 billion, according to IBES data from Refinitiv.

Bristol said it was pulling the application for Opdivo and low-dose Yervoy in patients whose tumours have specific characteristics - in this case, a biomarker called tumour mutational burden, or TMB - above a certain level. It made the decision after discussions with the U.S. Food and Drug Administration.

Last October, the possible approval date for the closely-watched combination therapy was pushed back by three months to late May, after the company submitted data showing no difference in survival rates between patients whose tumours had high or low TMB levels.

Read Also: FDA approves Bristol-Myers Opdivo for small cell lung cancer

Earlier this month, some analysts and investors suggested that one reason Bristol may have launched its bid for Celgene - the biggest pharmaceutical deal ever - was over concerns about Opdivo’s ability to compete in the all-important lung cancer market.

The New York-based drugmaker reported net earnings of $1.19 billion, or 73 cents a share in the quarter, compared with a loss of $2.3 billion, or $1.42 a share, last year, when it took a large charge related to U.S. corporate tax reform.

Excluding one-time items, Bristol-Myers said it earned 94 cents a share in the quarter. Analysts, on average, had expected 85 cents.

Bristol forecast adjusted earnings of $4.10 to $4.20 per share, excluding any impact from the Celgene deal.

Revenue of $5.97 billion was in line with analyst estimates.

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