The annual ASH (American society of hematology) meeting will take place next month in New Orleans. Based on the abstracts that were released 2 weeks ago, it seems that after 2 phenomenal years of introducing novel mechanisms, this year’s meeting is going to be more on the evolving landscape in each segment (Btk/PI3K inhibitors, antibody drug conjugates, myelofibrosis, CD38 antibodies, chimeric antigen receptors etc.).
Last month’s failure of Infinity’s (INFI) Hsp90 inhibitor (retaspimycin) has mixed implications for Synta (SNTA), whose Hsp90 inhibitor (ganetespib) is in phase III for lung cancer. On the one hand, ganetespib’s most advanced competitor is now eliminated but on the other, the failure raises doubt about targeting Hsp90 in lung cancer. In that sense, Infinity’s failure gives another reason to question the validity of Synta’s phase II results (that are already quite controversial). As background, I discussed Synta’s results here. Continue reading →
Last weekend, Synta (SNTA) reported updated results from a randomized phase II evaluating ganetespib in NSCLC (non-small cell lung cancer). Although the data set demonstrated a survival signal that merits advancing ganetespib to phase III, results were worse than last year’s interim analysis (discussed here). This triggered a sell-off in the stock, which was down 39% this week.
Putting disappointment aside, the clinical profile that emerges from the updated results is positive and should be regarded as reliable given the large size of the trial (252 patients). If these results are reproduced in the ongoing phase III, ganetespib will likely become a commonly used drug in 2nd/3rd line NSCLC patients with a clinical profile that resembles that of Avastin (Approved for 1st line NSCLC). Continue reading →
Below is a recap of interesting data expected to be presented at the Annual meeting of The American Society of Clinical Oncology (ASCO). This year’s meeting will have a strong focus on immunotherapy (PD-1 antibodies in particular) as well as novel oral agents for hematology. Companies for which important data are expected are reviewed as well.
PD-1 takes center stage
PD-1 antibodies are by far the hottest and most active field in cancer drug development. Although technically, all data to date were from phase I studies, there is wall to wall consensus that inhibitors of the PD-1 pathway will become a cornerstone in several cancer types and a $5-$10B franchise.
This is the second part of an article I posted back in April. The final list includes only 9 candidates, as one of the candidates (Seattle Genetics’ SGN-75) was taken off the list after generating fairly disappointing results at ASCO. Enjoy.
Micromet (MITI), who is developing antibodies for cancer, definitely has a potential game changer in its hands. The company’s lead agent, blinatumomab (Bmab), belongs to a new class of antibodies called BiTE (Bispecific T cell Engagers). These antibodies can harness the patient’s immune system to attack tumors by redirecting T cells (the most potent immune cells in the body) against cancer cells. BiTE antibodies achieve this by simultaneously binding a cancer cell on one side and an immune cell on the other. This unleashes a potent anti-tumor immune response. Continue reading →
2011 is shaping up as a transformational year for Synta (SNTA), who is making progress on multiple fronts with its lead agent ganetespib (formerly known as STA-9090). Ganetespib is an Hsp90 inhibitor, a protein with a well recognized role in cancer. The concept of inhibiting Hsp90 to fight cancer goes back two decades, but all attempts have been beset by failures so far. As Synta’s ganetespib appears to be the first active and safe Hsp90 inhibitor, it is poised to make a big dent in the multibillion dollar oncology market. I discussed the history of Hsp90 inhibitors and Synta’s unique positioning in a previous write up.)
In the pharmaceutical industry, it is very common to see multiple drugs in development that go after the same target. Usually, there is a direct correlation between the recognition a target has and the number of competing agents. This is the case with “hot targets” such as PI3K,RAF and mTOR, which are pursued by many pharma and biotech companies.
In most cases (especially with targeted therapies), the different compounds are being developed in parallel, and there is no way of identifying a clear winner. This can persist even after approval. For instance, both BMS Pfizer and Novartis (NVS) have an mTOR inhibitor on the market for the treatment of renal cancer. It is clear both drugs are active but each compound was approved based on a different trial in a different patient population, so neither can claim superiority.