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its multiple myeloma drug carfilzomib (Kyprolis), in various patient subgroups. That drug is currently being evaluated by the FDA, which has scheduled an advisory panel for June 20, and has a deadline to complete its review of the application by July 27. If Onyx can win FDA clearance for that drug, and follow that up with a winning application for regorafenib, it will go from being a one-drug company to being a three-drug company in relatively short order.
—Seattle Genetics’s brentuximab vedotin (Adcetris) for cancers that overexpress the CD30 biomarker. This company won FDA approval last August for brentuximab vedotin (Adcetris), a product designed as a “smart bomb” antibody drug like Genentech’s T-DM1. Seattle Genetics’s initial FDA approval was for patients with a couple of rare, relapsed forms of lymphoma—and now its task is to see how many other patients it can help. The company expects to roll out some preliminary results at ASCO on how well the drug works for non-Hodgkin’s lymphoma, for patients getting retreatment, and among patients with various solid tumors that happen to carry the CD30 marker that Adcetris is designed to hit.
—Johnson & Johnson’s abiraterone (Zytiga) for prostate cancer. J&J, the New Brunswick, NJ-based healthcare giant (NYSE: JNJ), made big news back in March when it said it stopped a clinical trial of its drug, abiraterone (Zytiga), earlier than expected after the drug was found to slow the spread of tumors when compared with a placebo in a study of more than 1,000 patients with prostate cancer. This trial represents an important expansion opportunity for J&J, which currently has an FDA approval for abiraterone among prostate cancer patients who have already gotten chemotherapy. The goal is for J&J to move into the bigger population of pre-chemotherapy patients. While the initial press release was written in such a way as to imply the data was so overwhelmingly positive that Zytiga must be extending survival time, the company clarified later in response to media inquiries that it hasn’t shown a statistically significant survival advantage yet.
Exactly what magnitude of benefit J&J is seeing will have a big impact not just on J&J, but also on competitors like Seattle-based Dendreon (NASDAQ: DNDN) and San Francisco-based Medivation (NASDAQ: MDVN). The competitive intelligence crews from both companies will be watching very carefully to see what J&J and its investigators have to say about this important trial, known as Study COU-AA-302.
—Exelixis’s cabozantinib for medullary thyroid cancer, prostate cancer & more. The South San Francisco-based company (NASDAQ: EXEL) has a full lineup of presentations coming up at ASCO on cabozantinib, which is designed to work by a dual mechanism, in which it cuts off blood flow to tumors and blocks a sort of master switch that sends signals allowing tumors to grow. Last year at ASCO, the company released intriguing data that said its drug could reduce bone lesions in about 80 percent of prostate cancer patients—which doctors said was unprecedented and meaningful to prostate cancer patients. Then in October, Exelixis said it passed a pivotal trial of this drug as a treatment for medullary thyroid cancer, and it expects to present those detailed results from the study at ASCO.
While Exelixis plans to seek FDA approval based on the data it will present at ASCO, investors are only mildly interested because MTC represents a small market. The company has broader plans for “cabo” as a treatment for prostate cancer, and it plans a total of nine different presentations in seven tumor types. “Cabo is more than just a bone drug and more than just a prostate cancer drug,” CEO Mike Morrissey says. “When you look at the totality of data we’ll present, it speaks to the depth and breadth of activity with cabo.”
Still, Exelixis will have to carefully watch its competitors at ASCO, particularly Medivation, says analyst David Miller of Biotech Stock Research. He argues that Exelixis has been “monumentally stupid” in its clinical development of cabozantinib, by focusing first on the most terminally ill patients with prostate cancer, rather than where it can reach a larger market of patients with earlier-stage disease. Exelixis’s prostate trials will take a long time to complete, and if Medivation’s drug enzalutamide shows a significant benefit in relieving bone pain of prostate cancer patients, it could minimize some of Exelixis’s advantage, Miller says.
—Medivation’s enzalutamide for prostate cancer. The San Francisco-based company released data earlier this year at one of the mini-ASCO conferences, the ASCO-Genitourinary Symposium, which showed that its drug offered a median survival advantage of 4.8 months for prostate cancer patients who had already undergone chemotherapy. That’s created a lot of excitement around Medivation’s drug already, and built anticipation for more details from its 1,000 patient study. The main things to look for are enzalutamide’s effect on pain, and on tumors that spread to the bones. While overall survival is the gold standard measurement of success among prostate cancer drugs, Medivation’s measurements count because there is increasing value being placed on quality of life and side effects of new prostate cancer treatments, Miller says.
—Ariad Pharmaceuticals’s ponatinib for chronic myeloid leukemia. The Cambridge, MA-based drug developer (NASDAQ: ARIA) stumbled in an FDA advisory panel in March with a new drug for sarcoma. Fortunately for Ariad, investors have turned the page to the next drug in Ariad’s pipeline, ponatinib for chronic myeloid leukemia. This drug is designed to improve upon kinase inhibitors like Novartis’s nolitinib (Tasigna) and Bristol-Myers Squibb’s dasatinib (Sprycel) by hitting a broader range of variants of the molecular target, BCR-ABL. Ariad has enrolled 450 patients in a study known as PACE, and reported some preliminary data last December at a medical meeting where it analyzed patients after a median follow-up time of 57 days. Now that more time has gone by, Ariad expects to present six months of follow-up data. Analysts are eager to see these results, because preliminary trials have suggested patients do better on the drug over time.
“We think the oral data presentation at 6-months on all patients at ASCO will show incrementally better efficacy and drive enthusiasm amongst physicians at the conference for it being a newer, better CML drug,” said Michael Yee, an analyst with RBC Capital Markets, in a note to clients May 9.
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