With this year's annual American Society of Clinical Oncology [ASCO] meeting coming up this weekend I thought I might give a heads up on a few companies whose presentations might look interesting to investors.
Unlike most years where the conference abstracts were unavailable to the public prior to the conference, this year the ASCO chiefs decided to make them public two weeks before the meeting. While quite often an abstract cannot be a substitute for seeing an entire presentation it can give you a heads up to where the most exciting (or disappointing) presentations will come from.
By far the most important data to be released will be from Imclone (IMCL) where the so-called FLEX study on Erbitux in non small cell lung cancer [NSCLC] will be presented at the plenary session (there was no abstract available for this study of course). Since it's been nine months since Imclone announced that this trial was positive there has been lots of speculation on exactly how good this data really is. It seems that the consensus by now, based on comments by Imclone's European partner Merck-AG (MRK), is that Erbitux showed no progression free survival [PFS] benefit and the overall survival benefit is likely to be about four or five weeks. It's due to the low expectations that Imclone is trading only slightly higher than where the stock was trading before Imclone announced that the FLEX study was positive.
So for the presentation on FLEX to have a big positive impact for the stock I think the overall survival rate would probably have to be at least five weeks. Another thing to look for is the overall side effect profile. If it's relatively benign that could boost the stock as well.
One thing to note though is that this FLEX study was unique in some ways in that it included all NSCLC patients not just those likely to benefit from Erbitux, unlike Genentech's Avastin which was only studied in non-squamous cell patients and excluded very sick patients. This is more of a real world look at the drug's benefit than most other trials and any real survival benefit should lead to both approval by the FDA and wide use by oncologists.
Also of importance to Imclone will be results from a study of Erbitux (and other drugs in the same class of EGFR inhibitor drugs like Amgen's (AMGN) Vectibix and OSI's (OSIP) Tarceva) in patients who have the KRAS mutation gene. It is generally assumed that patients who have this gene respond better to EGFR inhibitors than other patients, but analysts are divided as to whether the knowledge will lead to more use of EGFR inhibitors. Physicians will either be more likely to use them in those patients even possibly as a first line therapy, or less likely since physicians will be more reticent to use them in patients without the KRAS gene.
Moving onto other stocks of note, I for one am really excited about Incyte Pharmaceutical's (INCY) INCB18424, for the treatment of myelofibrosis, which is a disease which effects the bone marrow and causes enlargement of the spleen. The abstract showed there was a rapid and significant reduction in splenomegaly, with reductions from baseline of 53% at one month and 76% at three months. This could become the first drug ever approved for myelofibrosis and should rapidly advance through clinical trials.
Celgene (CELG) had some interesting data on a combination trial with the two leading drugs Velcade and Revilimid in multiple myeloma. The combination was better than using either as a single agent, and this could lead to the added use of both drugs.
Ariad Pharmaceutcals (ARIA) had some data which showed its oral version of the bone cancer drug deforolimus was better than its IV version, with a 25% response rate. The problem for ARIA though is that there is very tough competition in bone cancer from Amgens's denosumab, which has some outstanding Phase 2 data with an unheard of 85% response rate.
Regeneron (REGN) had some interesting early data of the company's VEGF Trap in brain tumors. The response rate in one type of tumor (glioma) was 50% and in the other (glioblastoma) was 30%. In comparison the early data for Avastin was about a 20% response rate.
Seattle Genetics (SGEN) should have impressive data on SGN-35 for the treatment of refractory Hodgkin's lymphoma. The abstract showed that 54% of patients at the higher dose levels had a partial response.
One tiny stock to look for is YM Biosciences [YMI], which has interesting early data on nimotuzumab in lung cancer and head and neck cancer. There is also an abstract for a phase 3 trial of the drug in glioma without any data. One thing to note on YMI though is that pivotal phase 3 data for nimotuzumab is due in the near term and that will likely be a make or break event for the company.
Finally, Immunogen (IMGN) should have updated data on it's TDM-1 linked with Herceptin at ASCO. Some investors seem to think that the drug has potential to become the standard of care for Herceptin refractory patients. The key for Immunogen will be if Genentech (DNA) decides to take the drug into phase 3 trials. A decision will likely be made later this year.
Long IMCL, INCY, CELG, IMGN.