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.
Abstract 5565 describes a phase II study of selinexor in patients with advanced ovarian, endometrial and cervical cancers no longer responding to prior therapies. The overall response rate for 30 ovarian cancer patients was 9% with a disease control rate (stable disease included) was 36%. In 15 patients with endometrial cancer, the response rate was 18%, disease control rate 64%. In 18 patients with cervical cancer, the response and disease control rates were 7% and 28%, respectively. Additional patients are enrolling in all disease cohorts. Selinexor dose reductions were required in 30% of patients, with most common adverse events reported to be nausea, thrombocytopenia, vomiting and fatigue.
ImmunoGen (IMGN): Abstract 5518 gives an early look at the efficacy and safety of the antibody-drug conjugate IMGN853, an important (perhaps the most important) wholly owned drug in ImmunoGen's pipeline. The phase I study enrolled 14 patients with platinum-resistant epithelial ovarian cancer. All the patients were heavily pre-treated with existing therapies and had tumors which over-expressed folate (the receptor target for IMGN853.) Among 10 evaluable patients, the overall response rate was 40% (four partial responses) with an additional patient having a confirmed CA125 response. Enrollment continues, and updated data is to be presented at the meeting.
Oncothyreon (ONTY): Abstract 602 summarizes data from a triplet therapy consisting of Oncothyreon's experimental ONT-380 combined with Xeloda and Herceptin in patients with heavily pre-treated HER2-positive breast cancer. (Prior treatments include Herceptin and Kadcyla.) The abstract contains data on eight patients: four partial responders and two stable disease. Two patients with partial response and both stable disease patients were treated previously with Perjeta.
Abstract 612 describes ONT-380 treatment combined with other therapies in patients with HER2-positive breast cancer that has spread to the central nervous system. Among eight evaluable patients, there were three partial responders and stable disease in four patients.
NewLink Genetics (NLNK): Several companies, including NewLink, are developing new drugs which work by blocking IDO, an enzyme found on tumor cells which prevents the immune system from identifying and killing cancer cells. Abstract 2070 describes an early study of NewLink's IDO inhibitor indoximod in patients with brain tumors no longer responding to temozolomide. Twelve patients were treated with indoximod plus temozolomide. The best response was stable disease in three patients lasting between five and 10 months, ongoing. One of the stable disease patients has tumor shrinkage almost great enough to be classified as a partial response.
Celgene (CELG) and Halozyme (HALO): Abstract 4006 describes a randomized phase II study investigating the use of Halozyme's PEGPH20 to enhance the ability of Celgene's Abraxane to penetrate and kill pancreatic cancer cells. Among 135 pancreatic cancer patients evaluable for response, PEGPH20 added to Abraxane resulted in an overall response rate of 34% compared to 23% for Abraxane alone. The difference was not statistically significant. Among a subset of patients with tumors expressing high levels of a substance known as hyaluronan, the PEGPH20-Abraxane response rate was 71% compared to 29% for Abraxane alone. A significant reduction in the rate of tumor progression was also seen with PEGPH20-Abraxane in the subset of "hyaluronan high" patients. On safety, the abstract notes an imbalance in blood clots reported by 42% of patients treated with PEGPH20 compared to 25% of patients in the control arm.