MedicalResearch.com Interview with:
Jeffrey Weber, M.D., Ph.D
Laura and Isaac Perlmutter Cancer Center
New York University Langone Medical Center
New York, NY 10016
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is a major unmet need for well tolerated and effective adjuvant therapy for high risk melanoma, that is, melanoma that has been removed but the patients have a 50%+ risk of relapse over 5 years, and a 50%+ risk of death over 10 years from melanoma. Since nivolumab is an active and well tolerated drug in metastatic disease, it seemed reasonable to test it after surgery to prevent recurrence. Since ipilimumab is approved for resected stage III melanoma in the US as adjuvant therapy, that was the control arm for comparison, and that is an active control, which prolongs relapse free and overall survival comared to placebo.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: That nivolumab is a new and effective adjuvant treatment that is well tolerated, and compared to the active control of ipilimumab , it is much better tolerated, and represents a major advance for the treatment of melanoma patients who have had their tumor removed surgically, but are at high risk of relapse.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
- We need to test IPI + NIVO versus NIVO alone for the highest risk patients, which we have already piloted at NYU; that would be particularly useful in PD-L1 negative patients.
2. We need to expand the indication to test nivo versus IPI in stage IIC and IID patients who have no positive nodes, but have deep primaries and are at a very high risk of relapse;
3. We should accrue more mucosal and acral lentiginous patients on the trial;
4. We need to study the relapsers’ tumor biology to see how prior nivolumab affects the biology of the patients’ tumors.
MedicalResearch.com: Is there anything else you would like to add?
Response: That credit goes to BMS for having confidence that a drug felt active only in the tumor microenvironment would be useful in the absence of gross disease as adjuvant therapy.
Disclosures: see the disclosures on the disclosure slide of the attached ESMO presentation.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Jeffrey Weber, M.D., Ph.D., Mario Mandala, M.D., Michele Del Vecchio, M.D., Helen J. Gogas, M.D., Ph.D., Ana M. Arance, M.D., Ph.D., C. Lance Cowey, M.D., Stéphane Dalle, M.D., Ph.D., Michael Schenker, M.D., Vanna Chiarion-Sileni, M.D., Ivan Marquez-Rodas, M.D., Ph.D., Jean-Jacques Grob, M.D., Marcus O. Butler, M.D., Mark R. Middleton, Ph.D., Michele Maio, M.D., Ph.D., Victoria Atkinson, M.B., B.S., Paola Queirolo, M.D., Rene Gonzalez, M.D., Ragini R. Kudchadkar, M.D., Michael Smylie, M.D., Nicolas Meyer, M.D., Laurent Mortier, M.D., Ph.D., Michael B. Atkins, M.D., Georgina V. Long, Ph.D., M.B., B.S., Shailender Bhatia, M.D., Celeste Lebbé, M.D., Ph.D., Piotr Rutkowski, M.D., Ph.D., Kenji Yokota, M.D., Naoya Yamazaki, M.D., Ph.D., Tae M. Kim, M.D., Ph.D., Veerle de Pril, M.Sc., Javier Sabater, Pharm.D., M.Sc., Anila Qureshi, M.D., M.P.H., James Larkin, F.R.C.P., Ph.D., and Paolo A. Ascierto, M.D., for the CheckMate 238 Collaborators*
September 10, 2017DOI: 10.1056/NEJMoa1709030
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