even after their disease had spread through the body and they had stopped responding to traditional treatment combinations of Herceptin, chemotherapy, or another targeted drug, GlaxoSmithKline’s lapatinib (Tykerb). Just two patients quit taking infusions of the drug because of side effects that were possibly drug-related, researchers said in December.
The abstract on the ASCO site doesn’t appear to say much more than the December presentation, but ImmunoGen noted that final results of this trial will be presented on May 30. This presentation will include important measurements on tumor shrinkage, how long the drug kept tumors from spreading, and how long the patients’ remissions lasted, ImmunoGen said in a statement.
—Infinity Pharmaceuticals (NASDAQ: [[ticker:INFI]]), the Cambridge, MA-based cancer drug developer, suffered a big setback last month when it halted a pivotal trial of patients with a rare form of cancer known as GIST, for gastrointestinal stromal tumors, after trial monitors saw a higher death rate among patients taking the treatment. This drug, IPI-504, is made to block a target on cells known as heat shock protein90, which operates like a chaperone for cells that help cancer cells survive and resist chemotherapies.
This trial, called RING, was closed, but Infinity is continuing to test it for other tumors, like non small-cell lung cancer, and in combination with Roche’s trastuzumab for breast cancer patients.
One abstract of data to be presented at ASCO shows IPI-504 was able to shrink tumors on its own in a study of 24 patients with non small-cell lung cancer that failed to respond to prior therapies. Two of the 24 had their tumors shrink by at least 25 percent, while seven patients had more modest reduction in their tumor volume, researchers said. The drug was considered well-tolerated, and was related to fatigue, nausea, and diarrhea.
—Cambridge, MA-based Biogen Idec (NASDAQ: [[ticker:BIIB]]) had some discouraging news to report from a mid-stage clinical trial of an antibody drug for ovarian cancer. The company reported on a clinical trial of 127 women who were randomly assigned to get Biogen’s experimental antibody drug, volociximab, in combination with a form of doxorubicin chemotherapy, or the chemo alone. The new drug didn’t appear to add any safety concerns, although it was halted early after researchers saw it had a low probability of keeping tumors from spreading any more than the standard treatment.
—Cambridge, MA-based Synta Pharmaceuticals (NASDAQ: [[ticker:SNTA]]) suffered a devastating setback in February when a clinical trial of 630 patients was shut down. The company pulled the plug after patients who were randomly assigned to get its novel drug for melanoma that has spread through the body showed a higher risk of death than those in a control group. Full results of this study weren’t made available in an abstract form on the ASCO site, although the final version will be made available on Saturday, May 30 at noon eastern time.
—Antigenics (NASDAQ: [[ticker:AGEN]]), the Lexington, MA-based developer of a treatment to stimulate the immune system against cancer, will provide an update on survival in a follow-up analysis of a pivotal clinical trial. The study failed to reach its main goal of lowering the risk of relapse after kidney tumors were removed, although it did help a subpopulation of 60 percent of patients in the study stay in remission longer, if they had a lower risk of recurrence to start with.
This sort of retrospective analysis is frowned upon by the FDA, which considers it a fishing expedition for positive data, and not compelling enough to warrant approval. So Antigenics took its application first to Russia, where it won approval to market the vitespen (Oncophage) treatment for the subpopulation of patients thought to benefit. The company is trying the same tactic in Europe.
The update on survival, which Antigenics hopes will buttress its case for vitespen, isn’t easy. Researchers have made contact with 306 patients out of 513 who were eligible, so the data aren’t complete, according to the abstract. So far, there appears to be a “favorable trend” toward longer survival times of patients on vitespen, although it’s too early to leap to any firm conclusion while statistical analyses are ongoing.
