R&D

Analysis: Pfizer tallies an impressive array of late-stage catalysts for cancer, gene therapies and more

Pfizer execs ran through their 2018 late-stage pipeline plan on Tuesday, highlighting the key catalysts that await during their Q4 call with analysts. And cancer drugs figured prominently in the discussion.

We won’t have long to wait before the news gets started.

Mikael Dolsten

First up, the Phase III PROSPER data for Xtandi, which is positioning itself against J&J’s next-gen drug for Zytiga. Pfizer and its partners at Astellas are anxious to get the FDA review underway for nonmetastatic prostate cancer, which could add considerably to its franchise value as generics start to slice and dice the market for J&J’s rival therapy Zytiga. J&J has a next-gen drug in late-stage development for nonmetastatic prostate cancer which is crucial to its near-term ability to compete with Pfizer.

Then there’s talazoparib, the PARP inhibitor that Pfizer acquired in the big $14 billion Medivation buyout, with positive late-stage data on BRCA-positive metastatic breast cancer.

Their PD-L1 inhibitor Bavencio, allied with Merck KGaA, stumbled badly on third-line gastric cancer recently. But researchers are following up on second-line non-small cell lung cancer and first-line renal cell carcinoma in combination with Inlyta. A triple combo using Bavencio, Pfizer’s 4-1BB agent, and their OX40 monoclonal antibody in solid tumors is being studied.

R&D chief Mikael Dolsten summarized the top oncology trials this way:

We have now five pivotal studies over the next 18 to 24 months with various Bavencio combinations that we think will be really interesting to watch. Ovarian second-line and third-line with chemo, renal first-line…, gastric first-line on maintenance of Bavencio after chemo, bladder first-line…Bavencio combined with various chemo combinations….”

And finally, I want to say that we are really one of the few that have both an IO agent Bavencio and a PARP inhibitor talazoparib and we do think that will be a very powerful combination and we’re running broad basket studies over many solid tumors and expect opportunities to take from those dataset into pivotal studies in the near term.

Ian Read, Pfizer CEO

Ian Read

Pfizer CEO Ian Read had this to add:

I would like to point out that while we are behind in lung now our expectations are we have two important readouts; one this year and one later on which is in – we have very creative design and let’s see what results are in lung and how positive it can be. We haven’t anyway given up and our attempt to participate in that large market.

Then Read ticked off three more top prospects in oncology: Lorlatinib for ALK-positive cases, the two-time loser dacomitinib — a TKI — that came through in EGFR mutated non-small cell lung cancer and glasdegib, an oral SMO inhibitor initially coded PF-04449913, for acute myeloid leukemia, based on Phase II results.

There’s a major Phase III program underway for their JAK1 in atopic dermatitis, a Phase III C diff vaccine and a big effort underway in gene therapies for hemophilia A and B — which inspired the pharma giant to spend $100 million on building a gene therapy manufacturing centering Sandford, NC.

Dolsten took on the pivotal program for the NGF pain drug tanezumab, partnered with Lilly. He said:

We are very excited about the trial of six different studies, 7000 patients that are starting to read out early fall this year and then each of the trials further on into 2019. We have a unique position in the space as we gathered tremendous experience and insight in how to manage our NGF antibody and deal with rare events….

Analysts have been rigidly focused on M&A at Pfizer, which put the BD team on pause as they waited for tax reform to come through. Now that that smoke has begun to clear, cutting Pfizer’s prospective tax rate by 6 points, to 17%, we’re likely to see the pharma giant get back into the M&A game as well. Now that Pfizer has lopped off neurosciences, it should have plenty of ability to add fresh programs to the pipeline. And Read’s track record suggests he’d like to stay focused on late-stage development.


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