Anti-PD-1 Adjuvant Therapy in Melanoma

Source: OnClive, December 2018

Transcript:

Axel Hauschild, MD: There’s also competition in the field. Two other treatments have been approved, at least in the United States. The approval for pembrolizumab in Europe is expected to happen over the next few weeks because of the positive CALGB [Cancer and Leukemia Broup B] opinion that is already out there for the drug. Likewise, nivolumab is approved in Europe. So we have the choice of either targeted therapies or PD-1 [programmed cell death protein 1]–driven therapies. But what are your impressions based on CheckMate 238? The data were presented for the first time a year ago at the ESMO [European Society for Medical Oncology] congress in Madrid. Do you see any differences versus KEYNOTE-054 on pembrolizumab, which has been presented on this year? Are there any differences between the PD-1 antibodies? What is your first choice for BRAF-mutated patients.

Michael A. Davies, MD, PhD: The design of the 2 studies was quite different. The Checkmate 238 study compared adjuvant nivolumab for a year versus adjuvant ipilimumab. And so, this had a control arm of an active therapy. The KEYNOTE-054 study compared adjuvant pembrolizumab versus placebo. And so, we have a different comparator. The second difference is that the Checkmate 238 study didn’t include patients with stage IIIa disease. This looked at stage IIIb, stage IIIc, and stage IV NED [no evidence of disease] patients. KEYNOTE-054 did include stage IIIa patients who had at least 1 millimeter of lymph node burden, as well as stage IIIb and stage IIIc patients. But it did not look at stage IV disease.

So again, there was a difference in the designs of the trials, both in terms of the patient populations and the comparators. Both trials showed that adjuvant PD-1 therapy is very safe and very effective. CheckMate 238 immediately replaced adjuvant ipilimumab as a therapy option with adjuvant PD-1. Again, we use it quite routinely in the United States. We do not use adjuvant pembrolizumab. This is not approved at this point in the United States, but probably will be in the near future.

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