Merck halts two cancer drug trials for lack of efficacy

RAHWAY, N.J. - Merck & Co., the pharmaceutical giant, announced today that it is ending two Phase 3 clinical trials, KEYNOTE-867 and KEYNOTE-630, after recommendations from independent Data Monitoring Committees (DMCs). The trials were studying the effects of KEYTRUDA, Merck's anti-PD-1 therapy, on non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma (cSCC), respectively.

The KEYNOTE-867 trial, targeting stages I and II NSCLC, was discontinued due to the therapy not meeting the primary endpoint of improving event-free survival (EFS) or the secondary endpoint of overall survival (OS) when combined with stereotactic body radiotherapy (SBRT), compared to the control group receiving SBRT and placebo. The trial also reported higher rates of adverse events, including those leading to death, in the treatment group.

Similarly, the KEYNOTE-630 trial for patients with high-risk locally advanced cSCC was ceased when the data indicated that KEYTRUDA did not achieve statistical significance for recurrence-free survival (RFS), the primary study goal. While overall survival was not formally tested at the time of analysis, the results did not favor the treatment over placebo.

Both decisions were based on the lack of sufficient benefit to patients to justify the risks associated with the treatment. Merck has advised patients involved in the studies to consult with their physicians about alternative treatment options. Despite these setbacks, Merck remains committed to exploring innovative cancer treatments, particularly for types of cancer with high unmet needs.

Non-small cell lung cancer is the most common form of lung cancer, representing about 80% of cases, while cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer. Both diseases represent significant challenges in oncology, with high incidences and mortality rates.

Merck's clinical program for KEYTRUDA is extensive, with over 1,600 trials across various cancers and treatment settings. The company aims to understand KEYTRUDA's role in cancer treatment and identify patients who might benefit most from the therapy.

The information regarding the halted trials is based on a press release statement from Merck. The company continues to analyze the data from these studies and plans to share the findings with the scientific community and regulatory bodies.

In other recent news, Merck & Co. has embarked on a series of significant developments. The company has initiated a Phase 3 clinical trial for bomedemstat, an investigational drug aimed at treating essential thrombocythemia, a rare blood disorder. The European Commission has also approved Merck's novel therapy, WINREVAIR, for the treatment of pulmonary arterial hypertension, marking the first activin signaling inhibitor therapy in the European Union.

In a noteworthy business move, Merck & Co. acquired CN201, a clinical-stage bispecific antibody, from Curon Biopharmaceutical for an upfront payment of $700 million. However, the company had to halt its Phase 3 KeyVibe-008 trial for the treatment of extensive-stage small cell lung cancer due to safety concerns.

Merck & Co's second-quarter results for 2024 surpassed market expectations, with significant organic sales growth in its CM&E and oncology franchises within the Healthcare sector, and in its Electronics division. The company upgraded its full-year 2024 guidance, expecting net sales between €20.7 billion to €22.1 billion.

Finally, the Biden administration initiated price negotiations with the Medicare health program for 10 prescription medicines, including Merck & Co's Januvia. These negotiations are expected to save the U.S. government $6 billion in the first year from reduced prices on these leading drugs.

InvestingPro Insights

As Merck & Co. navigates the challenges presented by the discontinuation of KEYNOTE-867 and KEYNOTE-630 clinical trials, the company's financial health and market position remain robust. An InvestingPro Tip highlights that Merck has raised its dividend for 13 consecutive years, showcasing a commitment to returning value to shareholders. Additionally, the company is expected to see net income growth this year, which may reflect its broader strategy to overcome setbacks in clinical trials with a strong portfolio of products and a focus on innovation.

Turning to real-time financial metrics from InvestingPro, Merck's market capitalization stands at a substantial $297.59 billion, underpinning its status as a prominent player in the Pharmaceuticals industry. Its Price/Earnings (P/E) ratio is currently at 21.6, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at 17.94. This indicates that investors may find the company's shares to be valued reasonably in relation to its earnings. Moreover, Merck's revenue growth over the last twelve months as of Q2 2024 is reported at a solid 7.15%, suggesting a healthy expansion in its business operations.

For those seeking additional insights and analysis, the InvestingPro platform offers more InvestingPro Tips on Merck & Co., which include information on the company's low price volatility, its ability to cover interest payments with cash flows, and its moderate level of debt. These factors can provide investors with a comprehensive understanding of the company's financial stability and potential risks. To explore these and other tips, readers can visit the dedicated page for Merck on InvestingPro.

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