Interim Data Due Out, This Morning, On Merck’s Melanoma Candidate, Lambolizumab — MK-3475

UPDATED | Noon | 11.18.13: At the outset, we should note that BMS’s Anti-PD-1 melanoma candidate, nivolumab, is about two years ahead of Merck’s MK-3475 candidate, here. Even so, the early Phase IB data shown by Whitehouse Station is. . . promising. It just may reach market a little too late to reap a full windfall, here. [Thus far — and we are still in Phase I here (safety; smaller studies — 165 patients) — side effects include general fatigue, itching, rash, diarrhea, joint pain, headache and nausea. Signs of liver damage and kidney failure occurred in two patients. So far, no autoimmune disorders have presented — see below the updated portion.]

This is a bit, from Bloomberg’s coverage of the morning’s Philly ICSMR meeting, then — do go read it all — 81 per cent are showing a continued one year response:

. . .“It looks quite promising,” said Eric Rubin, Merck’s vice president of oncology, in a telephone interview. “At one year, 81 percent of patients are alive, which in an advanced melanoma population is quite striking. Forty percent or less are typically alive at one year. . . .”

Do stay tuned — a nice data set, all in all, given the severity of the study-patients’ conditions. [END, UPDATED PORTION]

While we haven’t seen the data sets to be released yet, a prior anonymous commenter asked if there would appear an elevated risk for autoimmune diseases in the MK-3475 co-hort. It is likely that this commenter has scientific reason to ask the question.

It is fair to suggest (as he does) that — if you have late stage cancer, an elevated risk of a long-term autoimmune disorder may be an acceptable tradeoff — as death may loom without an oncology therapy regime. Will this data show anything along these lines — a statistically-significant elevated risk of autoimmune disorders? We will see.

Here is a bit of Merck’s press release, from Friday evening:

. . . .Merck will present additional data from patients with advanced melanoma from the Phase IB trial of MK-3475 on Monday, Nov. 18 at the 10th International Congress of the Society for Melanoma Research in Philadelphia. MK-3475 is Merck’s investigational anti-PD-1 immunotherapy. The additional data are from PN001, an ongoing multi-center, single-arm open-label study evaluating MK-3475 monotherapy in more than 1,000 patients with diverse late-stage cancers (metastatic carcinoma), predominantly lung and melanoma. The data to be presented are for patients in the melanoma cohort. . . .

We will report whatever emerges from Philadelphia this morning — to the extent that any of it contains any surprises.


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