Yesterday, Mr. Frazier Did “Tease” Merck’s ASCO Sunday (2 PM EDT) Lambrolizumab [MK-3475] Presentation

While I admit that I expect only to hear more detail — not anything fundamentally new — about MK-3475, Merck’s playfully-named “Lambrolizumab” melanoma candidate, at the annual meeting of the American Society for Clinical Oncology here in Chicago, this weekend, I will listen in to Merck’s webcast of its presentation on it, tomorrow at 1 PM local, 2 PM Eastern. In fact, I may just pop by McCormick Place. Here is the 2013 ASCO Meeting website.

If you decide you want to listen in, click here, and register with your name and a working email. But then Merck will have your name and email. [My earlier backgrounders are here, and here.]

Here is a bit of an abstract of the data to be presented and discussed at Merck’s ASCO briefing, tomorrow afternoon (and here is the link to the study page, on it):

. . . .As of December 1, 2012, 294 pts with MEL were enrolled, including 179 IPI-naive and 115 IPI-pretreated. Pts received lambrolizumab 10 mg/kg (n = 183) or 2 mg/kg (n = 111). Preliminary data from the first 85 consecutive pts dosed before April 25, 2012, who had independent radiologic review available as of December 3, 2012, indicate a confirmed overall response rate per RECIST 1.1 of greater than 35%, pooled across all doses and schedules and including both IPI-naive and IPI-pretreated patients.

The median duration of response has not been reached as only 2 pts who had initial response discontinued due to disease progression, but the duration of confirmed responses range from 28+ to 240+ days (up to 8+ months). Among 133 pts who were dosed with lambrolizumab before July 31, 2012, and evaluable for adverse events (AEs) as of September 28, 2012, fatigue (22%), rash (18%), and pruritus (14%) were the most common drug-related AEs (mostly grade 1/2).

The incidence of drug-related grade 3/4 AEs was 10% (24% regardless of attribution). Four drug-related cases of pneumonitis were reported, all of grade 1/2. Grade 3/4 drug-related hypothyroidism (n = 1) and hyperthyroidism (n = 1) were noted. Conclusions: Preliminary data suggest that lambrolizumab has significant antitumor activity and is well tolerated with manageable side effects in both IPI-naive and IPI-pretreated MEL pts. These data have led to an ongoing, international, randomized study of lambrolizumab versus chemotherapy in IPI-pretreated MEL. . . .

Later in the day on Sunday, I’ll post a recap — if something materially novel is disclosed.


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