On May 15, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2-6 (Press release, Merck & Co, MAY 15, 2023, View Source [SID1234631730]). Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA; LYNPARZA (olaparib), in collaboration with AstraZeneca; and WELIREG (belzutifan). Additionally, Merck will present data from its broad pipeline, including V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA, and MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech.
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"At this year’s ASCO (Free ASCO Whitepaper), data from our diverse portfolio and broad and expanding pipeline showcase how we continually challenge the status quo through our research to pursue meaningful advances in oncology," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "Building on our leadership with KEYTRUDA, which is now approved for 35 uses across 16 types of cancer, we will present compelling new investigational data from our expansive research program, including in earlier lines of therapy and stages of disease such as the KEYNOTE-671 study in non-small cell lung cancer, and data evaluating new combinations with KEYTRUDA."
Key data from Merck’s portfolio to be presented at ASCO (Free ASCO Whitepaper) 2023:
First-time data from the pivotal Phase 3 KEYNOTE-671 study, evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single-agent) for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) (Abstract #LBA100; The Promise of Neoadjuvant Immunotherapy Across Solid Tumors Clinical Science Symposium);
First presentation of results from the Phase 3 IND.227/KEYNOTE-483 trial in collaboration with the Canadian Cancer Trials Group (CCTG) evaluating KEYTRUDA plus chemotherapy as first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma (Abstract #LBA8505; Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session);
Final overall survival (OS) results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating KEYTRUDA plus LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC) (Abstract #4502; Genitourinary Cancer – Kidney and Bladder Oral Abstract Session);
Final distant metastasis-free survival (DMFS) data from the Phase 3 KEYNOTE-716 trial evaluating KEYTRUDA as adjuvant therapy for stage IIB and IIC melanoma (Abstract #LBA9505; Melanoma/Skin Cancers Oral Abstract Session);
Final OS results from the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA in combination with chemotherapy with or without bevacizumab, as first-line treatment for persistent, recurrent or metastatic cervical cancer (Abstract #5500; Gynecologic Cancer Oral Abstract Session), which will be featured as part of the ASCO (Free ASCO Whitepaper) press program.
Key data from Merck’s pipeline to be presented at ASCO (Free ASCO Whitepaper) 2023:
First presentation of DMFS data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating V940/mRNA-4157 in combination with KEYTRUDA as adjuvant treatment for high-risk melanoma (Abstract #LBA9503; Melanoma/Skin Cancers Oral Abstract Session);
Additional data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 evaluating minimal residual disease as a predictive biomarker of recurrence-free survival (RFS) in patients with high-risk melanoma treated with V940/mRNA-4157 in combination with KEYTRUDA (Abstract #LBA9515; Melanoma/Skin Cancers Poster Discussion Session);
Efficacy and safety data from a Phase 2 study evaluating MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate in advanced NSCLC (Abstract #9114; Lung Cancer – Non-Small Cell Metastatic Poster Session).
Merck investor event
Merck will host an Oncology Investor Event to coincide with the ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 5, 2023, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation at View Source
Details on abstracts listed above and additional key abstracts related to Merck portfolio and pipeline at ASCO (Free ASCO Whitepaper) 2023:
Central nervous system tumors
Belzutifan treatment for von Hippel-Lindau (VHL) disease–associated central nervous system (CNS) hemangioblastomas (HBs) in the phase 2 LITESPARK-004 study. O. Iliopoulos.
Abstract #2008, Central Nervous System Tumors Oral Abstract Session
Gastrointestinal cancers
Health-related quality of life (HRQoL) in the phase 3 KEYNOTE-966 study of pembrolizumab (pembro) plus gemcitabine and cisplatin (gem/cis) versus placebo plus gem/cis for advanced biliary tract cancer (BTC). C. Yoo.
Abstract #4003, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Oral Abstract Session
Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study. Y. Nakamura.*
Abstract #4007, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Oral Abstract Session
KEYNOTE-859 study of pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Outcomes in the protocol-specified PD-L1–selected populations. S. Young Rha.
Abstract #4014, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Poster Discussion Session
Genitourinary cancers
Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma: 5-year analysis of KEYNOTE-426. B. Rini.
Abstract #LBA4501, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session
Belzutifan plus lenvatinib for patients (pts) with advanced clear cell renal cell carcinoma (ccRCC) after progression on a PD-1/L1 and VEGF inhibitor: Preliminary results of arm B5 of the phase 1/2 KEYMAKER-U03B study. L. Albiges.
Abstract #4553, Genitourinary Cancer –Kidney and Bladder Poster Session
Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). T. Hutson.**
Abstract #4502, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session
First-line lenvatinib + pembrolizumab treatment across non-clear cell renal cell carcinomas: Results of the phase 2 KEYNOTE-B61 study. C. Lee.**
Abstract #4518, Genitourinary Cancer –Kidney and Bladder Poster Discussion Session
Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up. S. Gupta.
Abstract #4505, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session
Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data. T. Friedlander.***
Abstract #4568, Genitourinary Cancer –Kidney and Bladder Poster Session
Health-related quality of life (HRQoL) and pain outcomes for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone (abi) and olaparib (ola) versus (vs) abi and placebo (pbo) in the phase III PROpel trial. A. Armstrong.****
Abstract #5012, Genitourinary Cancer –Prostate, Testicular, and Penile Poster Discussion Session
Gynecologic cancers
KEYNOTE-826: Final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer. B. Monk.
Abstract #5500, Gynecologic Cancer Oral Abstract Session
Hematologic cancers
Efficacy and safety of pembrolizumab (pembro) in children and young adults with newly diagnosed classical Hodgkin lymphoma (cHL) with slow early response (SER) to front-line chemotherapy (chemo) in the phase 2, open-label, KEYNOTE-667 study. L. Vinti.
Abstract #10027, Pediatric Oncology Poster Discussion Session
Zilovertamab vedotin (MK 2140) in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Early results from the phase 2 waveLINE-004 study. M. Ozcan.
Abstract #7531, Hematologic Malignancies –Lymphoma and Chronic Lymphocytic Leukemia Poster Session
Efficacy and safety of pembrolizumab every six weeks in relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma: The phase 2 KEYNOTE-B68 trial. A. McDonald.
Abstract #7517, Hematologic Malignancies –Lymphoma and Chronic Lymphocytic Leukemia Poster Discussion Session
Lung cancer
SKB264 (TROP2-ADC) for the treatment of patients with advanced NSCLC: Efficacy and safety data from a phase 2 study. W. Fang. (Led by Kelun-Biotech)
Abstract #9114, Lung Cancer – Non-Small Cell Metastatic Poster Session
KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early stage NSCLC. H. Wakelee.
Abstract #LBA100, The Promise of Neoadjuvant Immunotherapy Across Solid Tumors Clinical Science Symposium
IND227 phase III (P3) study of cisplatin/pemetrexed (CP) with or without pembrolizumab (Pembro) in patients (pts) with malignant pleural mesothelioma (PM): A CCTG, NCIN, and IFCT trial. Q. Chu.*****
Abstract #LBA8505, Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session
Pembrolizumab vs placebo for early-stage non‒small-cell lung cancer after resection and adjuvant therapy: Subgroup analysis of patients who received adjuvant chemotherapy in the phase 3 PEARLS/KEYNOTE-091 study. K. Oselin.
Abstract #8520, Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Poster Discussion Session
Melanoma/skin cancer
Pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: Final analysis of distant metastasis-free survival in the phase 3 KEYNOTE-716 study. J. Luke.
Abstract #LBA9505, Melanoma/Skin Cancers Oral Abstract Session
Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial. A. Khattak.(Led by Moderna)
Abstract #LBA9503, Melanoma/Skin Cancers Oral Abstract Session
Minimal residual disease by circulating tumor DNA as a biomarker of recurrence free survival in resected high-risk melanoma patients treated with mRNA-4157/V940, a personalized cancer vaccine, and pembrolizumab. M. Carlino.(Led by Moderna)
Abstract #LBA9515, Melanoma/Skin Cancers Poster Discussion Session
Encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for unresectable locally advanced or metastatic BRAF V600-mutant melanoma: Results from STARBOARD safety lead-in (SLI). S. Schadendorf. (Led by Pfizer)
Abstract #9531, Melanoma/Skin Cancers Poster Session
NeoPlus: A phase II study of neoadjuvant lenvatinib and pembrolizumab in resectable mucosal melanoma. L. Mao.
Abstract #9514, Melanoma/Skin Cancers Poster Discussion Session