CHICAGO (TheStreet) -- ASCO's Abstract-A-Palooza is here.
I'm referring, of course, to the Wednesday in the middle of each May when the American Society of Clinical Oncology (ASCO) provides public access to 5,000 cancer drug trial research abstracts ahead of the group's big annual meeting.
The research abstracts went live on ASCO's website at 5 p.m. EDT today, which means health care investors are now busy downloading and reading to find investable, stock-moving nuggets of clinical data.
Luckily, I had early access to the ASCO abstracts under an embargo. What follows is a list and summary of abstracts likely to be of greatest interest to biotech investors. My list isn't comprehensive, but it should expedite your ASCO abstract search.
Note: A lot of the data covered in abstracts is preliminary, meaning updates will be presented at the ASCO annual meeting, May 29 through June 2. Also, late-breaking abstracts covering some of the most important cancer drug research data are withheld by ASCO until the meeting begins. These "LBA" abstracts are not available tonight.
Puma Biotechnology (PBYI): It's been almost one year since Puma announced the top-line results from the phase III ExteNET study of neratinib monotherapy after adjuvant Herceptin (extended adjuvant) in metastatic breast cancer patients. Results from the ExteNet study will be presented in detail at this year's ASCO meeting. Abstract 508 provides a sneak peek. The study's primary endpoint, as announced last July, hasn't changed: Treatment with neratinib demonstrated a statistically significant 33% improvement in disease-free survival compared to placebo. New data contained in the abstract includes the absolute disease-free survival in the study: 93.9% for neratinib versus 91.6% for placebo. The DFS difference of 2.3 percentage points between neratinib and placebo may disappoint investors given buy-side expectations were in the 3-4 percentage point range. Also, 40% of patients treated with neratinib experienced grade 3 diarrhea (which didn't allow for prophylactic use of immodium.)
Celldex Therapeutics (CLDX): Sorry to disappoint, but there are no new data in abstract 2009 describing the Rintega "ReAct" study in patients with recurrent brain tumors. Updated results will be presented at the meeting.
Clovis Oncology (CLVS): The rociletinib lung cancer abstract 8001 includes an analysis of overall response using two different screening methods for the T790 mutation. The abstract does not contain updated rociletinib results (progression-free survival and overall response rates) from the study overall, but those important data will be included in the oral presentation at the ASCO meeting.
Karyopharm Therapeutics (KPTI): Selinexor is being investigated in several phase III studies of blood cancers, but the company is also seeking to broaden clinical development into solid tumors. Abstract 2044 describes an open label, phase II study of selinexor in patients with recurrent glioblastoma, a form of brain cancer. Two different dose regimens of selinexor (seven patients in Arm A, 15 patients in Arm B) were enrolled. Investigator-derived responses from 12 evaluable patients in Arm B were two partial responses (17%), four stable disease (33%) and six progressive disease (50%.) Primary toxicities were fatigue and anorexia.