Merck and AstraZeneca’s Phase 3 Trial of KEYTRUDA + LYNPARZA Fails in Metastatic Castration-Resistant Prostate Cancer
Mar 22, 2022 02:26
CST Updated
02:26
MSD
Pharmaceutical R&D and Manufacturer
Prostate Cancer (Image Source: hopkinsmedicine.org)
News on March 21, 2022 /BioValleyBIOON/ -- MSD (Merck & Co) announced that it will discontinue the Phase 3 KEYLYNK-010 trial (NCT03834519). The trial was conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed after receiving chemotherapy and androgen receptor (AR) antagonist Zytiga (abiraterone acetate) or Xtandi (enzalutamide), and was evaluatingTumorEfficacy and Safety of the Combination Therapy with Immune Checkpoint Inhibitor PD-1 Antibody Keytruda (Pembrolizumab) and Targeted Drug PARP Inhibitor Lynparza (Olaparib).
After the independent Data Monitoring Committee (DMC) reviewed the planned interim analysis data, MSD decided to stop this study based on the DMC’s recommendation. In the interim analysis,Compared with the control group of abiraterone acetate or enzalutamide, the Keytruda+Lynparza combination therapy group did not show benefits in overall survival (OS).OS is one of the dual primary endpoints of the study.
The trial'sAnother dual primary endpoint was radiographic progression-free survival (rPFS), which was evaluated in an early interim analysis. Compared with the control group, the combination of Keytruda and Lynparza did not show improvement.
In the trial, the safety of the combination of Keytruda and Lynparza was consistent with what had been observed in previous studies of each drug; however, the incidence of grade 3-5 adverse events and drug-related serious adverse events was higher in the combination group compared to the control group.
MSD will inform the study investigators about the DMC's recommendations and advise patients participating in the study to discuss their treatment with their doctors. The data from this study will be presented at an upcoming scientific conference.
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at Merck Sharp & Dohme AG (MSD) Research Laboratories, stated: "For thoseDiagnosisFor patients with advanced prostate cancer, there remains a significant unmet need as these patients have poor prognoses after initial treatment. MSD will continue to evaluate the combination of Keytruda and Lynparza across a range of cancers and investigate other Keytruda-based combinations for the treatment of advanced prostate cancer. We thank the patients, their families, and the researchers who made this study possible.”
MSD has a broad clinical development program in prostate cancer, evaluating Keytruda as a monotherapy and in combination with Lynparza and other anticancer therapies. Ongoing trials assessing Keytruda include Phase 2.Clinical TrialKEYNOTE-199 and KEYNOTE-365, as well as the Phase 3 registration trials KEYNOTE-641, KEYNOTE-921, and KEYNOTE-991.
Through withAstraZenecaIn collaboration, MSD is evaluating the Phase 3 trial of Lynparza in combination with abiraterone acetate.Clinical TrialKEYLYNK-010 is one of several trials evaluating the combination of Keytruda and Lynparza; in addition to metastatic prostate cancer, this combination is also being studied in advanced lung cancer, ovarian cancer, triple-negativeBreast Canceras well as in solid tumors with certain biomarkers. (Bioon.com)