European Commission approves Opdivo-Yervoy combo for liver cancer

PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY), a pharmaceutical giant with $48.3 billion in revenue and an impressive 75% gross profit margin according to InvestingPro data, has received approval from the European Commission (EC) for its combination treatment of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adults with advanced liver cancer, specifically unresectable or advanced hepatocellular carcinoma (HCC). This marks a significant advancement in the therapeutic options available for patients with this type of cancer in the European Union and associated countries.

This approval is grounded in the results from the Phase 3 CheckMate -9DW study, which indicated a notable improvement in overall survival for patients treated with the Opdivo plus Yervoy combination compared to those who received lenvatinib or sorafenib, the investigator’s choice of treatment. The median overall survival was 23.7 months for the combination therapy versus 20.6 months for the alternative treatments. The study also showed a higher overall response rate in the Opdivo plus Yervoy group.

According to Dana Walker, M.D., M.S.C.E., vice president and Opdivo global program lead at Bristol Myers Squibb, the approval by the EC underscores the potential of dual immunotherapy to extend survival for patients suffering from hepatocellular carcinoma. The safety profile of the combination remained consistent with previously reported data, with no new safety signals identified.

The EC’s approval is valid across all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. Additionally, Opdivo-based treatments are approved for multiple tumor types within the EU. As a prominent player in the pharmaceuticals industry with a market capitalization of $122 billion, Bristol Myers Squibb continues to strengthen its market position. InvestingPro analysis indicates the stock is currently trading near its 52-week high, suggesting strong market confidence in the company’s growth trajectory. This recent development follows the U.S. FDA’s acceptance of the supplemental Biologics License Application for Opdivo plus Yervoy as a potential first-line treatment for unresectable HCC, with a decision expected by April 21, 2025.

Hepatocellular carcinoma is the most prevalent form of liver cancer and is often diagnosed at an advanced stage, leading to limited treatment options and poor outcomes. With the EC’s approval, patients in Europe now have access to a new treatment that has demonstrated a clinically meaningful improvement in survival.

The information in this article is based on a press release statement from Bristol Myers Squibb. For investors seeking deeper insights, InvestingPro offers comprehensive analysis of BMY’s financial health, including over 10 additional ProTips and a detailed Pro Research Report, helping investors make informed decisions about this pharmaceutical leader’s potential.

In other recent news, Bristol Myers Squibb has declared its latest quarterly dividends, with shareholders set to receive $0.62 per share on common stock and $0.50 per share on convertible preferred stock. These dividends reflect the company’s financial health and commitment to providing value to its shareholders. Meanwhile, the U.S. Food and Drug Administration has accepted a supplemental biologics license application from Bristol Myers Squibb for a dual immunotherapy treatment for colorectal cancer, granting it Breakthrough Therapy Designation and Priority Review status. This development is supported by positive results from the Phase 3 CheckMate -8HW clinical trial.

In another significant update, Bristol Myers Squibb released the final analysis of the CheckMate -816 study, showing that Opdivo combined with chemotherapy significantly improves overall survival for patients with resectable non-small cell lung cancer. However, the company faced a setback in its Phase 3 RELATIVITY-098 trial, as Opdualag did not meet the primary endpoint of recurrence-free survival for melanoma patients. Despite this, Opdualag continues to be a standard treatment for unresectable or metastatic melanoma.

Additionally, BTIG’s Jonathan Krinsky noted that Bristol Myers Squibb’s previous resistance levels in the healthcare sector are now transforming into support, indicating potential positive momentum. These developments highlight Bristol Myers Squibb’s ongoing efforts in research and development, as well as its strategic focus on delivering innovative treatments across various cancer types.

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