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Pivotal New Data from Merck’s Broad Oncology Portfolio at ESMO 2019 Congress

Nachrichtenquelle: Business Wire (engl.)
09.09.2019, 12:45  |  462   |   |   

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from its broad oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions.

“The breadth of data to be presented at ESMO reflect our company’s commitment to advance KEYTRUDA and the other medicines in our portfolio across cancer types and stages of disease to help improve outcomes for cancer patients,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Five years ago, KEYTRUDA received its first worldwide approval, and today new KEYTRUDA data will be presented at ESMO across more than 15 types of cancer, including first-time results in triple-negative breast cancer, in addition to new data for LYNPARZA, LENVIMA and our investigational candidates.”

Key abstracts to be presented at ESMO include:

  • First presentation of results from the pivotal Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant therapy in patients with TNBC, which will be featured in the ESMO Presidential Symposium and Press Program (Abstract #LBA8). As previously announced, KEYNOTE-522 met one of the dual primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with TNBC. Based on an interim analysis, KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.
  • First presentation of results from the Phase 3 PROfound trial evaluating Merck and AstraZeneca’s PARP inhibitor LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) selected for BRCA 1/2 or ATM gene mutations, a subpopulation of homologous recombination repair gene mutations (HRRm), and who have progressed on prior treatment with new hormonal anticancer treatments. These data will be featured in the ESMO Presidential Symposium and Press Program (Abstract #LBA12). As previously announced, the PROfound trial met its primary endpoint, showing a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared to enzalutamide or abiraterone.
  • First presentation of results from the Phase 3 PAOLA-1 trial evaluating LYNPARZA plus bevacizumab as maintenance therapy in patients with advanced ovarian cancer who responded to first-line platinum-based chemotherapy and bevacizumab, which will be featured in the ESMO Presidential Symposium and Press Program (Abstract #LBA2). As previously announced, PAOLA-1 met its primary endpoint, significantly reducing the risk of disease progression or death in women taking LYNPARZA plus bevacizumab versus those taking bevacizumab alone.
  • First presentation of final results from the endometrial cohort from the Phase 1b/2 KEYNOTE-146/Study 111 trial evaluating KEYTRUDA plus LENVIMA in patients with advanced endometrial carcinoma (Abstract #994O) (in collaboration with Eisai).
  • Presentation of final results from the pivotal Phase 3 KEYNOTE-407 study evaluating KEYTRUDA plus chemotherapy in patients with metastatic squamous non-small cell lung cancer (NSCLC) (Abstract #LBA82).
  • Initial results from the KEYNOTE-869/EV-103 trial evaluating KEYTRUDA plus enfortumab vedotin in locally advanced or metastatic urothelial cancer (Abstract #901O).
  • A first-in-human Phase 1/2 trial of the oral HIF-2a inhibitor PT2977 in patients with advanced renal cell carcinoma (RCC) (Abstract #911PD). PT2977 is now part of Merck’s broad early stage oncology pipeline following the acquisition of Peloton Therapeutics.

Details on Abstracts Listed Above & Other Late-breaking and/or Proffered Paper Sessions

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