Recent Keytruda Trial Approvals and Expansions
Keytruda (pembrolizumab) gained FDA approval in October 2024 for first-line treatment of head and neck squamous cell carcinoma (HNSCC) in combination with chemotherapy, based on KEYNOTE-689 phase 3 trial results showing improved overall survival.[1] In September 2024, it was approved with carboplatin and paclitaxel followed by single-agent Keytruda for primary advanced or recurrent endometrial carcinoma, from the phase 3 NRG-GY018 trial demonstrating 37% reduction in death risk.[2]
Key Ongoing Phase 3 Trials in 2024
Merck's KEYNOTE-671 trial supported full approval in March 2024 for perioperative use with chemotherapy in resectable non-small cell lung cancer (NSCLC), reducing risk of death by 28% and recurrence by 25%.[3] KEYNOTE-564, a renal cell carcinoma adjuvant trial, showed 38% reduction in death risk, with data presented at ESMO 2024 reinforcing long-term benefits.[4] Enrollment continues in KEYNOTE-B68 for neoadjuvant/adjuvant therapy in high-risk early-stage triple-negative breast cancer.[5]
Emerging Combinations and Novel Indications
Keytruda combined with Lynparza (olaparib) met its primary endpoint in the phase 3 KEYLYNK-006 trial for metastatic castration-resistant prostate cancer, with overall survival data expected in 2025.[6] In small cell lung cancer, the KEYNOTE-604 trial update at IASLC 2024 confirmed prolonged OS benefit with chemotherapy.[7] Early signals from KEYNOTE-995 show potential in neoadjuvant colorectal cancer with MSI-H/dMMR tumors.[8]
Challenges and Delays in Key Trials
The KEYNOTE-483 trial in mesothelioma faced scrutiny after missing OS endpoints in some subgroups, though it holds approval based on prior data; full results are due mid-2025.[9] Regulatory filings for gastric cancer from KEYNOTE-859 are pending EMA review amid debates on biomarker requirements.[10]
Upcoming Readouts and Patent Timeline
Investors watch for 2025 readouts from KEYNOTE-Z10 (NSCLC maintenance) and KEYVIBE-010 (early NSCLC with vibostolimab), potentially expanding indications.[11] Keytruda's main U.S. composition-of-matter patent expires January 2028, with pediatric exclusivity to July 2028; challenges from generics like Viatris continue via inter partes review.12
[1]: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-head-and-neck-squamous-cell-carcinoma
[2]: https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-in-combination-with-carboplatin-and-paclitaxel-as-treatment-for-primary-advanced-or-recurrent-endometrial-carcinoma/
[3]: https://www.merck.com/news/mercks-keytruda-pembrolizumab-approved-in-us-for-treatment-of-patients-with-resectable-non-small-cell-lung-cancer/
[4]: https://www.esmo.org/oncology-news/keytruda-improves-survival-in-kidney-cancer
[5]: https://clinicaltrials.gov/study/NCT05255653
[6]: https://www.merck.com/news/merck-announces-keytruda-pembrolizumab-plus-lynpaza-olaparib-demonstrated-significant-improvement-in-progression-free-survival-compared-to-lynparza-alone/
[7]: https://www.iaslc.org/iaslc-news/press-release/keynote-604-final-overall-survival-analysis
[8]: https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3505
[9]: https://www.merck.com/news/merck-announces-final-overall-survival-results-from-phase-3-keynote-483-trial/
[10]: https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
[11]: https://www.merck.com/research/clinical-trials/
[12]: https://www.drugpatentwatch.com/p/tradename/KEYTRUDA