MSD has reached an agreement with NHS England to make pembrolizumab available in England for eligible patients with metastatic MSI-H/dMMR colorectal cancer as an interim treatment option during the COVID-19 pandemic period.
Pembrolizumab was granted a European license for this indication in January 2021[i], and the agreement between MSD and NHS England reflects priorities of broader NHS treatment guidelines, offering alternative cancer therapies where they are clinically indicated to meet patient needs and fulfil certain criteria, including helping to reduce patient visits to hospital, making better use of clinical capacity, and providing options which reduce the number of patients on more immunosuppressive therapies, during the pandemic.[ii][iii]
Pembrolizumab was granted a license in this indication based on data from the KEYNOTE-177 study. In this phase 3, open-label trial, 307 previously untreated patients with metastatic MSI-H/dMMR colorectal cancer were randomly assigned, in a 1:1 ratio, to receive either pembrolizumab or chemotherapy.7 In the study, pembrolizumab significantly reduced the risk of disease progression or death by 40% compared with chemotherapy (median, 16.5 vs. 8.2 months; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.80; P=0.0002).[vii] In addition, treatment-related adverse events of grade ≥3 occurred in fewer patients treated with pembrolizumab versus chemotherapy (33 (22%) versus 94 (66%), respectively), with the exception of grade ≥3 immune-related or infusion-related events, with more occurring in the pembrolizumab group versus chemotherapy (14 (9%) versus 3 (2%), respectively).7 Analysis of the other dual primary endpoint of overall survival is ongoing.7
The interim treatment guidance provides for the use of pembrolizumab in England within its licensed indication for the first-line treatment of adult patients with metastatic MSI-H/dMMR colorectal cancer.2 The recommended dose of pembrolizumab as monotherapy is either 200mg every 3 weeks or 400mg every 6 weeks given as an IV infusion over 30 minutes, therefore providing clinicians with a choice of dosing regimens for their patients.[viii]
Dr Kai-Keen Shiu, Consultant Medical Oncologist at UCLH NHS Foundation Trust, Honorary Associate Professor in Oncology at UCL Cancer Institute and UK Chief Investigator for the KEYNOTE-177 trial said: “This is great news for our NHS patients, many of whom contributed to the success of this benchmark international trial of pembrolizumab as a 1st line treatment for MSI-High/MMR-deficient metastatic bowel cancer. I am glad that we can now offer eligible patients a treatment option which has been shown in the KEYNOTE-177 trial to be more effective in terms of halting tumour progression than chemotherapy and shown to have more manageable side-effects. For some patients, access to this treatment option could truly be life-changing.”
David Peacock, Managing Director, MSD UK and Ireland said: “With the unprecedented pressure the NHS is facing due to the COVID pandemic, we want to do all we can to support the NHS and ensure cancer patients and healthcare professionals have the very best treatments and care available to them. Everyone’s safety is paramount. With that in mind MSD is pleased to be able to contribute by working with NHS England to extend this treatment option for eligible patients with metastatic bowel cancer.”
The NHS England interim treatment options during the COVID-19 pandemic can be accessed here.
[i] European Commission. Union Register of medicinal products for human use. KEYTRUDA. https://ec.europa.eu/health/documents/community-register/html/h1024.htm. Accessed online February 2021.
[ii] NHS England. NHS England interim treatment options during the COVID-19 pandemic. https://www.nice.org.uk/guidance/ng161/resources/nhs-england-interim-treatment-options-during-the-covid19-pandemic-pdf-8715724381. Accessed online March 2021.
[iii] NICE. COVID-19 rapid guideline: delivery of systemic anticancer treatments. https://www.nice.org.uk/guidance/ng161. Accessed online March 2021.
[vii] Andre, T et al. “Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer.” N Engl J Med 2020; 383:2207-2218. DOI: 10.1056/NEJMoa2017699. https://www.nejm.org/doi/10.1056/NEJMoa2017699
[viii] Electronic Medicines Compendium. Pembrolizumab Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/2498. Accessed online February 2021.
[ix] NICE. Pembrolizumab for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency ID1498. https://www.nice.org.uk/guidance/indevelopment/gid-ta10420. Accessed online February 2021.