It is new to me, anyway, that MRL is also running an early, small (primarily) safety study, in certain previously-treated non-small cell lung cancer patients. That study is showing some decent results, at first blush. So that is some minor good news for Whitehouse Station, post a rather rough day yesterday, on earnings. The NYSE traders tackled Merck for an over 2.4 per cent price sack, yesterday over the thinning pipeline, slowing Januvia growth and generally ho-hum quarter. That top line sales were light -- even against reduced Wall Street expectations -- is of concern, longer term.
So, today, Merck is touting some happy news. But this won't ever move the needle, to be sure. It is just not material, to a multinational $47 billion a year in sales pharma company. Here's a report from Drug Discovery & Development, just the same. Do go read it all:
. . . .The data were presented by Dr. Edward Garon, director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, at the 15th World Conference on Lung Cancer in Sydney, Australia.
Detailed interim data were presented for response rates and safety from a cohort of 38 previously-treated NSCLC patients who received MK-3475 10mg/kg every three weeks as well as initial findings from an analysis of the relationship between response rates and PD-L1 expression.
“We are encouraged by these initial responses in NSCLC patients,” said Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories. . . .
We will keep you posted, but 38 people is truly. . . waifish. My advice? Just don't read too much into this. But it is encouraging, just the same. Of course, oncologists may always write off label, for non-small lung cancer, once it is approved by FDA for melanoma. . . the reimbursement might get tricky -- but it can be done. So. . . stay tuned.
will come down to pd1 status : An analysis of the relationship between PD-L1 expression status and response rates in this NSCLC patient cohort was also presented. Tumor samples were analyzed and classified as expressing either zero/low or high levels of PD-L1. High levels of expression according to the assay criteria, were associated with response rates of 67 percent (6/9) [95% CI; range 30, 93] per irRC and 57 percent (4/7) [95% CI; range 18, 90] per RECIST. In comparison, tumor samples expressing zero/low levels of PD-L1, according to assay criteria, were associated with response rates of 4 percent (1/24) [95% CI; range 0, 21] per irRC and 9 percent (2/22) per RECIST [95% CI; range 1, 29]. Data from more patients are needed to better understand the relationship between PD-L1 expression and response to MK-3475.
ReplyDeleteCool! Thanks -- and I'll not presume to doubt your analysis.
ReplyDeleteWe will see if Lambrolizumab will be approved by FDA for melanoma shortly, and then be prescribed off-label (or investigationally, if you prefer) for non-small cell lung cancers.
THen it will take some creative positioning to get a fair reimbursement from insurers and the Medicare/Medicaid payer systems, for that technically unapproved use.
Do stop back! Thanks for the keen insights!
Namaste