March 4, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Doctors hosted by market research firm Cowen and Company said this week that they are bullish on breast cancer drugs Perjeta and PD-1/PDL1, but remain cautious on Palbociclib and Neratinib as they await new trial data, analyst Boris Peaker said Wednesday.
Cowen hosted a breast cancer expert panel with doctors Eric Winer and Ian Krop on Tuesday, March 3, at their healthcare conference. Both of the panelists are academic physicians at Harvard Medical School. They focused discussion on the clinical and commercial potentials for palbociclib, Perjeta, neratinib, glembatumumab, Keytruda and Roche ‘s MPDL3280A.
“At our Therapeutics Conference in November 2014 our consultants were bearish on the approvability of palbociclib based on the PALOMA-1 study due to single arm design without a survival benefit,” wrote Peaker in a note to investors. “While the drug was recently approved (ahead of its PDUFA date), our consultants appear to be more bearish than the audience regarding commercial adoption, citing that only a small fraction of patients is likely to benefit.”
Ongoing PALOMA-2 and PALOMA-3 studies may significantly sway their view, and data are expected in late 2015, while the MARIANNE study will not change their use of Kadcyla and are looking to detailed data analysis. Specifically, the physicians would like to know if there is a patient subgroup that may have derived the greatest benefit from Kadcyla treatment.
“Consistent with their opinions at our November 2014 conference, both of our panelists were bearish on neratinib, raising concerns about delay to full data release (expected at ASCO 2015) and the diarrhea side effects,” said Peaker.
Overall the consultants present are more bullish about Perjeta in the extended adjuvant setting, wishing to see only a 3 percent progression-free survival for Perjeta vs. 4-5 percent PFS improvement for neratinib to use these drugs broadly. The higher hurdle for neratinib is due to diarrhea side effect. One physician said that if neratinib is approved he may start treatment in 30-40 percent of eligible patients, but anticipates a much smaller fraction to remain on drug for the full year.
“Only one of our panelists was familiar with glembatumumab, and he was positive on the prior data for the drug and bullish on the outcome of the METRIC study,” said Beaker. “This physician believes that the drug will be a welcomed option in the triple negative setting given a lack of good options. However, this consultant would like to see at least Phase II data outside of triple negative setting prior to expanding his use of glembatumumab.”
