The FINANCIAL — Merck, known as MSD outside the United States and Canada, announced on September 21 that new data investigating the anti-tumor activity of KEYTRUDA (pembrolizumab) across a broad range of advanced cancers will be presented at this year’s European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29. In total, 15 KEYTRUDA-related abstracts across nine difficult-to-treat cancers will be presented at this year’s ECC – including four late-breaking oral presentations.
First-time data looking at PD-L2 expression in multiple tumors to assess the potential value of this biomarker in patient responsiveness to anti PD-1 therapies will also be presented. With these and other presentations, data on the potential role of KEYTRUDA will have been presented in more than 17 different cancers.
Studies accepted into this year’s ECC program also include the investigation of KEYTRUDA monotherapy in anal cancer, biliary tract cancer, colorectal cancer, Merkel cell carcinoma (a type of skin cancer), nasopharyngeal carcinoma (a type of head and neck cancer), and non-small cell lung cancer (NSCLC), as well as a study evaluating KEYTRUDA in combination with another immunotherapy treatment in melanoma.
“As we continue to build our growing body of clinical data expanding our understanding of the potential for KEYTRUDA, we are also committed to identifying factors that may help us determine which patients are most likely to respond best to an individual medicine or approach,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “The initial data we are seeing with regard to PD-L2 expression now point to the potential relevance of dual PD-L1 and PD-L2 blockade in anti-PD-1 therapy for cancer treatment.”
KEYTRUDA, Merck’s anti-PD-1 therapy, is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. The KEYTRUDA clinical development program has rapidly expanded to encompass more than 30 tumor types in more than 130 clinical trials, of which more than 70 trials combine KEYTRUDA with other cancer treatments. Registration-enabling trials of KEYTRUDA monotherapy are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, and Hodgkin Lymphoma, with further trials in planning for other cancers, according to Merck.
“At Merck, we are rapidly expanding our clinical studies for KEYTRUDA in a wide range of cancers with the goal of potentially providing cancer patients with promising new options, and helping physicians identify which approaches may be best for an individual patient,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. “We look forward to sharing these new data at the European Cancer Congress as we continue to focus on bringing the breakthrough science of immuno-oncology to as many patients as possible.”
Merck’s Immuno-Oncology Data at European Cancer Congress 2015
A listing of the KEYTRUDA late-breaker, oral and poster sessions are included below:
Late-Breaker Oral Presentations
(Abstract #18LBA) PD-L2 expression in human tumors: relevance to anti-PD-1 therapy in cancer. J. Yearley. Sunday, Sept. 27, 10:05 AM CEST. Location: Hall A1.
(Abstract #24LBA) Safety data from the phase 1b part of the MASTERKEY-265 study combining talimogene laherparepvec (T-VEC) and pembrolizumab for unresectable stage IIIB-IV melanoma. G. Long. Sunday, Sept. 27, 12:00 PM CEST. Location: Hall A2.
(Abstract #33LBA) Efficacy and safety of pembrolizumab (pembro; MK-3475) for patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC) Enrolled in KEYNOTE-001. J.C. Soria. Monday, Sept. 28, 10:50 AM CEST. Location: Strauss.
(Abstract #22LBA) Activity of PD-1 blockade with pembrolizumab as first systemic therapy in patients with advanced Merkel cell carcinoma. P. Nghiem. Sunday, Sept. 27, 11:30 AM CEST. Location: Hall A2.
Oral Presentations
(Abstract #2801) Antitumor activity and safety of pembrolizumab in patients with PD-L1–positive nasopharyngeal carcinoma: Interim results from a phase 1b study. C. Hsu. Saturday, Sept. 26, 10:45 CEST. Location: Hall C1.
(Abstract #500) Pembrolizumab (MK-3475) for PD-L1–positive squamous cell carcinoma (SCC) of the anal canal: Preliminary safety and efficacy results from KEYNOTE-028. P. Ott. Sunday, Sept. 27, 5:05 PM CEST. Location: Hall D1.
(Abstract #502) Pembrolizumab (MK-3475) for patients (pts) with advanced colorectal carcinoma (CRC): Preliminary results from KEYNOTE-028. B. O’Neil. Sunday, Sept. 27, 5:35 PM CEST. Location: Hall D1.
Poster Sessions
(Abstract #507) Evaluation of patients with progressive metastatic head and neck cancer treated with PD-1 inhibition with pembrolizumab and radiation therapy: Assessment of local and systemic effects. T.Y. Seiwert. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #523) Initial clinical experience with pembrolizumab in metastatic heavily pre-treated patients with solid cancers in a single institution. R. Leibowitz-Amit. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #525) Safety and efficacy of pembrolizumab (MK-3475) in patients (pts) with advanced biliary tract cancer: Interim results of KEYNOTE-028. Y.J. Bang. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST (5:15 PM-6:15 PM CEST spotlight session). Location: Hall C.
(Abstract #2860) Correlation between plasma Epstein-Barr virus DNA and clinical response to pembrolizumab in patients with advanced or metastatic nasopharyngeal carcinoma. H.F. Kao. Sunday, Sept. 27, 9:15 AM-11:15 AM CEST. Location: Hall C.
(Abstract #2866) Antitumor activity of the anti-PD-1 antibody pembrolizumab in subgroups of patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Exploratory analyses from KEYNOTE-012. L. Chow. Sunday, Sept. 27, 9:15 AM-11:15 AM CEST. Location: Hall C.
(Abstract #3325) Safety and efficacy of pembrolizumab (MK-3475) for Japanese patients (pts) with advanced melanoma: Preliminary results from KEYNOTE-041 Phase 1b study. K. Yokota. Sunday, Sept. 27, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #3344) Relationship between pembrolizumab exposure and efficacy/safety in 1016 patients (pts) with advanced or metastatic melanoma. S.P. Kang. Sunday, Sept. 27, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #2622) A Phase I/II study to assess the safety and efficacy of pazopanib (paz) and pembrolizumab (pembro) in patients (pts) with advanced renal cell carcinoma (aRCC). D.F. McDermott. Monday, Sept. 28, 4:45 PM-6:45 PM CEST. Location: Hall C.
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