Merck, a global healthcare company, announced new data investigating the anti-tumour 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, September 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 tumours 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 programme 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-tumour immune response. The Keytruda clinical development programme has rapidly expanded to encompass more than 30 tumour 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.
“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. “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.”
Keytruda 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. Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The most common adverse reactions (reported in at least 20 per cent of patients) were fatigue (47 per cent), cough (30 per cent), nausea (30 per cent), pruritus (30 per cent), rash (29 per cent), decreased appetite (26 per cent), constipation (21 per cent), arthralgia (20 per cent), and diarrhea (20 per cent).
The recommended dose of Keytruda is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with Keytruda.