Pharmacyclics impresses (again) with improved leukemia data on blockbuster hopeful

Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the biotech had to offer analysts over the weekend.

Pharmacyclics ($PCYC) reported on Sunday that the 10-month follow-up data on its low-dose formulation of PCI-32765, a Btk inhibitor, looks better than the six-month data it's gathered in a small Phase Ib/II study. A total of 70% of the 61 chronic lymphocytic leukemia patients in the trial demonstrated a significant response, compared to 48% at the six-month mark. Progression-free survival hit 90% at six months,

All of the patients had failed at least two standard therapies for leukemia. The response rate in the high-dose group hit 44%. Lead author Dr. John Byrd of Ohio State called the data "phenomenal."

"In the 15 years I've been practicing as a CLL-specific specialist, this is by far the most phenomenally active drug for refractory CLL patients in terms of response and durability and tolerability," Byrd told HemOnc Today. "Eighty-six percent of people receiving this drug are progression free at 1 year. Given the durability and the potential that patients can stay on therapy for an extended period of time without adverse events, it's likely this is going a paradigm-shifting drug."

J&J ($JNJ) presumably agreed with that upbeat assessment. On Friday Janssen committed an old-fashioned blockbuster upfront to buy into the program, demonstrating once again that the Big Pharma company is willing to dig down into its very deep pockets to jump into a late-stage program that has been significantly de-risked. J&J will now help orchestrate a range of Phase III studies for the treatment.

- here's the Reuters story
- get the article from HemOnc Today

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