We have discussed this. The primary endpoint was not significantly successful. Phase II studies are not designed for efficacy of benefit. It would have been nice if there was a significant difference (P < 0.05) but the difference is not enough based on the sample size. There appears to be indication that there is improvement in overall survivial, but we would need more patients to make sure this is the case.
Gastric cancer, is not a very common malignancy. H/N and colorectal are much more common...and nimo should be used for these indicatoins. The gastric cancer and Gliomas are fine, but money should be spent to prove efficacy of these first cancers for improvement, as they are already used in India and other places in the world.
I think with 30-40 million a large phase III trial for H/N cancer can be done, or colorectal, and we can find improvement.
The reality is that according to Dean, and others, and along with the filing from the company, they are putting NIMO research on hold due to funding issues. It is surprising that the company is not seeking partnership with other pharmas to be able to test the medication.
I suggest people write the company in this regard. I did.
JAK appears to be the hot topic and apparently, is worth 4-5 dollars per share with current share count. Let's hope this is done ASAP.
Well they already had a phase 2 colorectal trial that failed a couple of years ago. I think they later determined that that was because the patient population wasn't EGFR-positive. It's unclear to me from things they've said whether that was because colorectal patients in general aren't EGFR-positive or because the patients in that trial were pre-administered irinotecan, which suppresses EGFR. (I realize the patients in the gastric trial also got irinotecan, but it appears from the poster that they got it concurrently with nimo.)
According to YMI's corporate presentation, its partner in Southeast Asia, Kuhnil Pharma/Innogene Kalbiotech, is conducting a randomized P3 trial in head and neck. If it's successful I'm not sure in which countries registration could occur, but I believe YMI would share in the revenues.
I don't have time to research it now but I believe gastric is a major cancer in Japan and elsewhere in Asia. I'm not sure why FDA approval would be needed if they wanted to market nimo only in that area.
I'm definitely not an expert, but was struck by the following:
The conclusions section says "These findings suggest that the selection of gastric cancer patients by EGFR status might be effective for the future study of nimotuzumab. A phase III study WILL be performed to examine these findings." That's stronger than the statement in YM's PR that the abstract's authors conclude that a P3 study "should" be performed. Not sure how much importance to attach to that.
While the number of EGFR-positive patients was tiny, at least the trend was in the right direction. If you look at the whole study population of 82 (still not powered for statistical significance), which includes both EGFR-positive and EGFR-negative patients, there was no statistically significant difference in the study's primary endpoint of PFS. But there was a nice trend in favor of the nimo group in the secondary endpoint of OS, which undoubtedly would be the primary endpoint in a P3 trial.
I think at the time this study was designed, YMI and Daiichi hadn't yet figured out that nimo appears to work only in EGFR-positive patients. That became evident only in trial results that were announced in the last couple of years. But YMI has made a big point of that selectivity for awhile now, so it's not "data mining" to look at the results in the EGFR-positive subgroup here.
Some here have suggested that YMI would need a partner to do the P3. It seems to me they already have one in Daiichi, which I assume would decide whether to do the P3. Gastric cancer is widespread in Japan but much less so in the U.S. and Europe so I don't think they need to involve the FDA. If someone thinks I'm missing something there, please explain.
No. A partnership would require discussion with the FDA in developing a phase 3 protocol. Daichi would need to follow FDA guidelines for this to be useful for YMI. I don't know if they are.
In regards to Nimo, we have the following to look forward to:
Daiichi also launched a Phase II trial in first-line NSCLC for which YM has been advised that recruitment has been completed. Reports on both trials are expected during the first half of calendar 2011 as data mature. Oncoscience AG (OSAG), CIMYM's licensee for Europe, reported safety data from a Phase III trial in adult glioma patients at ASCO 2010 and OSAG continues to recruit patients into a Phase IIb/III trial in pancreatic cancer patients. We are now advised by OSAG that data from the adult glioma trial may be released in the first half of 2011.
Too bad Kastlem got chased out, I would have like to hear her point of view.