Pfizer has notched another win for the late-stage drug pipeline, scoring an accelerated FDA approval for lorlatinib, now headed for the market as Lorbrena.
The drug is an ALK/ROS1 TKI for metastatic non-small cell lung cancer — the latest in a line of these drugs — now approved as a second-line treatment for patients who have failed crizotinib and at least one other ALK inhibitor. And you can be sure that Pfizer didn’t pass on the chance of boasting about its third cancer drug OK in the past 2 months, following approvals for its PARP talazoparib and dacomitinib.
There’s a lot about this drug that illustrates the current state of cancer drug development. Pfizer picked up an accelerated OK on positive Phase I/II data that will need to be borne out by pivotal results. Regulators were happy to provide a fast green light for a drug that fits in the treatment spectrum in the wake of a failure on alectinib, brigatinib or ceritinib.
The key data points from their Phase II posted a year ago:
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%.
ALK-positive lung cancer covers about a 5% slice of the overall market, limiting the upside for Pfizer. But with the change of the guard underway at Pfizer’s C-suite, the pharma giant insists it can rely on its late-stage pipeline to deliver the added revenue it needs to please Wall Street. And that followed their decision to back off price hikes for H2.
Or is that just window dressing for the giant pharma operator known for an aggressive M&A strategy to beef up its portfolio?
“I expect our approach by the end of year will be, what I would characterize as business as normal,” CEO Ian Read told analysts about their 2019 pricing strategy. And that has been widely interpreted as meaning more price hikes ahead.
Pfizer fielded the first TKI for ALK-positive cases, Xalkori, 7 years ago. But it’s been a big target for rivals. Novartis’ Zykadia picked up an FDA approval to challenge Xalkori in frontline ALK-positive lung cancer in mid-2017. And Roche’s Alecensa came along soon after.
The game plan now is to fight back for its share of the franchise, with the FDA’s breakthrough drug designation to help back up their campaign. And Pfizer wants to move as quickly as possible into frontline use for lorlatinib, expanding its potential.
“The last decade has witnessed dramatic improvements in the treatment of metastatic ALK-positive non-small cell lung cancer due to earlier generation ALK biomarker-driven therapies. Yet almost all patients still relapse due to drug resistance, with a large proportion of patients developing new or worsening brain metastases,” said Alice Shaw, a professor at Harvard Medical School and director of the Center for Thoracic Cancers at Massachusetts General Hospital.
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