Findings Show Anti-Tumor Activity for KEYTRUDA in Two Gastrointestinal Cancers

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The FINANCIAL — Merck, known as MSD outside the United States and Canada, on September 27 announced new findings from the KEYNOTE-028 Phase 1b study, the clinical trial investigating the use of the company’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in multiple, difficult-to-treat cancers. Data from this trial, to be presented at the European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29, include the first-time findings for KEYTRUDA in two gastrointestinal cancers, advanced anal cancer and advanced biliary tract cancer, and add to Merck’s growing body of clinical data for KEYTRUDA.

KEYNOTE-028 is an ongoing multi-cohort, non-randomized Phase 1b basket trial – a trial design that allows for the study of multiple sub-populations of different tumor or histological types within one study. The study is evaluating the safety, tolerability, and anti-tumor activity of KEYTRUDA monotherapy (10 mg/kg dosed every two weeks) in more than 450 patients across 20 different types of cancer. The study was designed to evaluate patients with advanced solid tumors that express PD-L1 and which have not responded to current therapy or for which current therapy is not appropriate, according to Merck.

“Through innovative trials like KEYNOTE-028, we are advancing our understanding of the potential benefit of KEYTRUDA in a wide range of difficult-to-treat cancers,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “Merck is committed to evaluating KEYTRUDA across as many tumor types as possible and the expansion of our clinical development program over the years reflects this. We are encouraged by these early stage data, and will continue to advance KEYTRUDA in order to deliver on our goal of helping as many people with cancer as possible.”

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, non-small cell lung cancer (NSCLC), head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, and Hodgkin Lymphoma, with further trials in planning for other cancers.

Early Findings from Advanced Squamous Cell Carcinoma (SCC) of the Anal Canal (Abstract #500)

Early findings from 25 heavily pre-treated patients with advanced anal cancer – to be presented in an oral session on Sunday, Sept. 27 by Dr. Patrick Ott, Dana-Farber Cancer Institute – demonstrated an overall response rate (ORR) of 20 percent (confirmed and unconfirmed) (95% CI, 6.8-40.7) and a disease control rate (DCR) of 64 percent (95% CI, 42.5-82.0). Five partial responses (95% CI, 6.8-40.7) were observed, and 44 percent of patients (n=11/25) had stable disease (95% CI, 24.4-65.1). Additionally, the 6-month progression-free survival (PFS) rate was 31.6 percent and the 12-month PFS rate was 19.7 percent. At the time of the analysis, response duration ranged from 0.1+ to 9.2+ months, with the median not yet reached. The median stable disease duration was 3.6 months (range, 1.8+ to 11.0+).

Adverse events were generally consistent with previously reported safety data for KEYTRUDA. Grade 3-4 investigator-assessed, treatment-related adverse events were thyroid-stimulating hormone increased (n=1), colitis (n=1), diarrhea (n=1), and general physical health deterioration (n=1). Immune-mediated adverse events were hypothyroidism (n=3) and colitis (n=1). There were no treatment-related deaths.

Early Findings from Advanced Biliary Tract Cancer (Abstract #525)

Early findings from 24 heavily pre-treated patients with advanced biliary tract cancer – presented in a poster session on Saturday, Sept. 26 by Dr. Yung-Jue Bang, Seoul National University Hospital, Seoul, Korea – demonstrated an ORR of 17.4 percent (confirmed and unconfirmed) (95% CI, 5.0-38.8) (n=4/23); 17.4 percent of patients had stable disease (95% CI, 5.0-38.8) (n=4/23). As the time of the analysis, three of four responses were ongoing, and the median response duration had not yet been reached (range, 5.4+ to 9.3+ weeks).

Adverse events were generally consistent with previously reported safety data for KEYTRUDA. Grade 3-4 investigator-assessed, treatment-related adverse events were anemia (n=1), autoimmune hemolytic anemia (n=1), colitis (n=1) and dermatitis (n=1). Immune-mediated adverse events were autoimmune hemolytic anemia (n=1), colitis (n=1), hypothyroidism (n=1), and hypothyroidism (n=1). There were no treatment-related deaths.


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