Merck & Co Halts Keytruda Trials Following Unsuccessful Outcomes
Merck & Co (MSD) has discontinued two Phase III trials for Keytruda, its immunotherapy drug, citing unmet primary and secondary endpoints. The KEYNOTE-867 trial, which combined Keytruda with stereotactic body radiation therapy (SBRT) to treat non-small cell lung cancer, did not demonstrate improvements in event-free survival or overall survival. Furthermore, this combination resulted in elevated rates of adverse events, including fatalities, compared to SBRT and placebo.
The other trial, KEYNOTE-630, designed to assess Keytruda for adjuvant treatment of locally advanced cutaneous squamous cell carcinoma, was terminated due to futility, as Keytruda did not achieve statistical significance in recurrence-free survival. MSD has notified study investigators and advised participants to consult with their study team for further guidance.
In addition to these discontinuations, MSD recently abandoned another Phase III trial, KeyVibe-008, for failing to meet its primary endpoint. Despite these setbacks, MSD remains committed to sharing the full trial results with the scientific community and regulatory agencies. Keytruda, although facing challenges, saw global sales of approximately $25 million in 2023, with forecasts pointing to a peak of around $34.3 million in 2027.
Key Takeaways
- MSD terminates two Phase III Keytruda trials due to unmet primary and secondary endpoints.
- KEYNOTE-867 fails to improve event-free survival and overall survival in non-small cell lung cancer patients.
- KEYNOTE-630 trial for cutaneous squamous cell carcinoma was stopped due to futility.
- Keytruda combination therapies exhibit higher adverse event rates, including deaths.
- MSD intends to share complete trial results with the scientific community and regulatory agencies.
Analysis
The halt of Keytruda trials by Merck & Co presents potential implications for investors and healthcare providers, possibly leading to stock value decreases and changes in treatment protocols. These failures underscore the challenges associated with immunotherapy combinations, impacting future research and development strategies and regulatory approvals. Short-term consequences may include financial and reputational damage for Merck, while long-term effects could involve adjustments in drug development and patient care. Nonetheless, the transparency of sharing trial data encourages scientific advancement and discussions on patient safety.
Did You Know?
- Phase III Trials:
- Phase III trials represent the final stage of clinical trials before a drug can be approved for general use. They involve a large number of participants to confirm the drug's effectiveness, monitor side effects, and compare it with standard or equivalent treatments.
- Keytruda (Pembrolizumab):
- Keytruda serves as a type of immunotherapy drug recognized as a checkpoint inhibitor. Its mechanism involves blocking the PD-1 receptor on the surface of T cells, aiding the immune system in recognizing and attacking cancer cells. Keytruda primarily targets various cancers, including melanoma, lung cancer, and head and neck cancer.
- Stereotactic Body Radiation Therapy (SBRT):
- SBRT represents a highly precise form of radiation therapy that delivers a substantial radiation dose to a tumor in a minimal number of treatments. It is employed in treating early-stage lung cancer and other localized tumors, known for its accuracy and ability to minimize damage to surrounding healthy tissues.