Tuesday, June 3, 2014

Nivolumab's FDA Jacket Ought To Catch Up To Merck's By End Of August; Thousands Previously Near Death Have Hope -- Of Years Of Cancer Free Living

The data is profoundly impressive enough -- and add to it that the BMS trials are designed so that Phase III approvability will be established in weeks, not months. In short, BMS and Merck are again in a dead heat at FDA -- for approvability Advisory Committee meetings by as early as late August 2014. And we KNOW with these sorts of remission and survival rates, oncologists will readily write off label, if insurers will reimburse.

It is a heady time, indeed -- and this is a $35 billion a year market opportunity (come 2016, when under full-sails). Here is the latest, via PharmaTimes, from ASCO:

. . . .In the [Nivolumab] study, 94 patients with inoperable stage III or IV melanoma were injected with the combination of checkpoint inhibitors every three weeks.

After two years of follow-up (one year data has been previously reported) the response rate in this patient population (with few other treatment options) was 41%, with nine patients experiencing a complete remission. The same percentage of patients had a greater than 80% reduction in tumour mass.

More importantly, after two years of follow-up the median overall survival rate of the cohort was 79%, at an average time of 39.7 months. “Now, even though this is a small trial,” said Dr Sznol, “This is an impressive two-year overall survival.”

To put the results in context, previously. . . the median survival for these patients was as little as one year, with less than 25% of such patients surviving as long as two years. . . .

The combined use of two new agents that boost the immune system has demonstrated an unprecedented improvement in tumour regression and overall survival for patients with advanced melanoma. . . .

This is a moment it would be hard to over-state -- an astonishing moment in the science of cancer treatments. You see -- people who, prior to Nivolumab or Pembrolizumab (each with Yervoy, generically called ipilimumab) were literally on their death-beds, have sat up, dusted their immune systems off, kicked it (their self healing powers) into high gear -- and walked away -- largely in remission; certainly no longer considered near death. Jaw-slacking indeed! A time of wonder.

1 comment:

Anonymous said...

you saw this~~right?