First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the adjuvant treatment for patients with BRCA -mutated ( BRCA m), human epidermal growth factor receptor 2 (HER2)-negative high recurrent risk breast cancer. This approval was based on results from the Phase 3 OlympiA trial published in The New England Journal of Medicine in June 2021. In the trial, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo. LYNPARZA also demonstrated a statistically
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First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA for the adjuvant treatment of patients with germline BRCA -mutated (g BRCA m), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. The CHMP based its positive opinion on results from the Phase 3 OlympiA trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine in June 2021. Breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. In
KEYTRUDA plus chemotherapy before surgery significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy (24.3% vs. 15.6%, respectively) KEYNOTE-756 is the first positive Phase 3 study with an immunotherapy regimen to demonstrate a statistically significant improvement in pCR rate in the neoadjuvant setting for this patient population Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the neoadjuvant part of the Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by KEYTRUDA plus endocrine therapy as adjuvant treatment, for patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response (pCR), demonstrating a
Biomarker testing may help inform treatment decisions in certain cancers
Over the past 20+ years, there’s been an evolution in how we think about cancer. Cancer biomarkers — substances produced by tumor cells that reflect unique features of a tumor — can change the approach to certain cancers. Advances in biomarker testing may help inform treatment decisions It wasn’t long ago when conversations were about […]
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA -mutated ( BRCA m) castration-resistant prostate cancer with distant metastasis (mCRPC). This approval by the Japanese Ministry of Health, Labor and Welfare was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZA plus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.23 [95% CI, 0.12-0.43]) and overall survival (OS) (HR=0.39 [95% CI, 0.16-0.86]) versus abi/pred alone in patients with BRCA m mCRPC. In the BRCA m subgroup (n=85), the median rPFS and median OS were not reached (NR) for patients receiving
KEYTRUDA® (pembrolizumab) plus chemotherapy before surgery significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy KEYNOTE-756 is the first positive Phase 3 study with an immunotherapy regimen to demonstrate a statistically significant improvement in pCR rate in the neoadjuvant setting for this patient population Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Committee (DMC), the KEYTRUDA-based regimen demonstrated a
Teaming up with Eisai to help fight cancer
Combining two ambitious cancer research teams to form a united front to help people with cancer It’s sometimes said that the whole is greater than the sum of its parts. That’s why in 2018 we teamed up with Eisai, a global pharmaceutical company headquartered in Japan, to work together to advance cancer research. “Combining Merck’s […]
https://www.merck.com/stories/teaming-up-with-eisai-to-help-fight-cancer/
First Phase 3 survival data from KEYNOTE-A39/EV-302 support potential benefit of combination approach in previously untreated locally advanced or metastatic urothelial cancer; data are selected for ESMO Presidential Symposium Session and official Press Briefings Key data to be presented for KEYTRUDA® (pembrolizumab) in earlier stages of cancer across multiple tumor types, including presentation of overall survival results from KEYNOTE-671, and new and updated data from KEYNOTE-A18, KEYNOTE-522 and KEYNOTE-756 First Phase 3 data from LITESPARK-005 trial highlight potential of WELIREG® (belzutifan) in certain previously treated patients with advanced renal cell carcinoma Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, from Oct. 20-24.
LYNPARZA combination showed a clinically meaningful reduction in risk of disease progression or death in these patients in the Phase 3 PROpel trial First approval of a PARP inhibitor in combination with a new hormonal agent in mCRPC AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZA plus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI,
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed). The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies. A full evaluation of the data from this study