After getting skunked by rivals, Pfizer touts ‘breakthrough’ cancer drug lorlatinib, heads to the FDA

Mace Rothenberg, Pfizer

Pfizer’s Xalkori has become a Phase III punching bag of sorts for top rivals in the cancer field. In June Novartis’ Zykadia picked up an FDA approval to challenge Xalkori in frontline ALK-positive lung cancer. And Roche’s Alecensa has been whupping up on Xalkori as well, proving better at cutting the risk of disease progression.

So it’s no wonder that Pfizer is taking its positive Phase II data — posted today — for its next-gen successor lorlatinib straight to regulators.

Now in Phase III, Pfizer won a breakthrough therapy designation for lorlatinib from the FDA earlier this year, promising a speedy review at an agency that has become a master at making accelerated cancer drug decisions.

Designed for ALK-positive and ROS1-positive advanced non-small cell lung cancer, researchers highlighted a slate of the mid-stage data on the drug.

The key data points:

  • In ALK-positive treatment-naïve patients, the overall response rate was 90%. The intracranial ORR (IC-ORR) was 75%.
  • For ALK-positive patients previously treated with Xalkori (crizotinib) with or without chemotherapy: ORR was 69%, the IC-ORR was 68%.
  • In ALK-positive patients previously treated with a non-crizotinib ALK inhibitor with or without chemotherapy: ORR was 33%.
  • ALK-positive previously treated with two or three prior ALK inhibitors with or without chemotherapy: ORR was 39%.
  • ROS1-positive regardless of prior treatment: ORR was 36%.

Now look for Pfizer to press hard to punch back at Novartis and Roche in defense of its cancer drug franchise. Pfizer’s made oncology a chief focus in the pipeline, scoring some of its biggest gains in the field as it added new drugs through the Medivation buyout. And as billions gets poured into new research, patients have benefited from the quick adoption of some game-changing therapies.

“Lorlatinib is an extraordinary example of what can be achieved through translational research and precision medicine development. Recall that Xalkori (crizotinib) was the first drug approved for patients with ALK-positive and ROS1-positive NSCLC. By understanding the mutations that occurred in patients that rendered their tumors resistant to Xalkori and other ALK inhibitors, medicinal chemists working at Pfizer were able to design a molecule with the potential to overcome that resistance and inhibit ALK despite these mutations. We are very encouraged by the results of this Phase 2 trial that provide the first clinical evidence of the activity of lorlatinib in this setting,” said Mace Rothenberg, chief development officer, oncology, Pfizer global product development.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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