From ESMO news release: "Although a large, phase III trial of tivantinib plus erlotinib for the treatment of patients with locally-advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) did not meet its primary endpoint of prolonging overall survival, promising progression-free survival and overall response rate results were seen in these patients."
The complete story in the ESMO website under the NEWS link.
The key takeaway from the new data, I believe, is the response of the hi C-MET patients, a pre-specified subgroup (page 17 of the presentation). The OS in that group was 9.3 for the Tivantinib group vs. 5.9 for the placebo group. The hazard ratio was .70. I think these results look pretty good in that sub-population.
Since your sentiment is strong buy I assume you believe this is a large enough sub-population to warrant continued development by Arqule and Daiichi Sankyo -- correct? Will it bring in enough cash for Arqule to continue to develop other treatments further down the pipeline?
nothing we didn't know in that release but obviously fact that arql didn't bother with a PR to provide some detail about met+ results, says it all. Hope we can stay above $2 tomorrow. At 9:30 on Friday I was hoping "somebody knew something" but not the case. Now on to Australia with kras one of the very few chances left for T.
The Marquee results for Met-High group is very positive: HR=0.7 and p=0.03 (the results are stat-significant).
In other word, OS was significantly improved and this improvement was stat-significant. The same goes for PFS and RR. If Marquee was ONLY for MET-High pts, Tiva would be easily approved by FDA.
It is of interest that Tiva also benefited Met-Low pts but OS improvement was very small but PDS and RR were very good. Remember that Roche's MetMab is highly detrimental to Met-Low pts.
KRAS-m pts did not see any benefits in ITT general NSCLC population.
However, it is correct, ARQL/Daiichi did not bother to issue a press-release with these positive information. There are many questions ARQL will be forced to answer.
This what you have having a shjty management and shjty partner,