Back in 2017 when Ipsen purchased Merrimack Pharmaceutical’s pancreatic cancer drug, Onivyde, in a potentially $1 billion deal, the company aimed to strengthen its oncology portfolio. Now, the drug is proving its worth in an earlier treatment setting.
Onivyde, combined with chemotherapy in the so-called Nalirifox regimen, helped patients live longer compared with chemotherapy in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in a phase 3, Ipsen said Wednesday.
The latest win puts Onivyde on track to move up the treatment ladder following an initial FDA nod in 2015 for previously treated pancreatic cancer. Ipsen will file an application for the combination with the FDA, following a previous fast-track designation.
The drug is currently approved in the U.S., Europe, and Asia in combination with fluorouracil and leucovorin as a treatment for mPDAC after disease progression and following gemcitabine-based therapy.
The agressive cancer sees about 60,000 new diagnoses in the U.S. each year, and fewer than 20% survive longer than one year, making survival a crucial trial endpoint.
So far this year, Ipsen’s oncology franchise has garnered 1.77 billion euros in sales, raking in 603.1 million euros this quarter in a 1.2% increase at constant exchange rates since last year’s third quarter. Onivyde contributed 38.8 million euros to that this quarter and 122 million euros this year. The 5.3% decrease since last year's third quarter was contributed to “the impact of the phasing of 2022 sales” to the drug's ex-U.S. partner, PharmaEngine.
But Ipsen has more moves up its sleeve to boost its oncology performance. In June, the company secured a $247 million deal to snap up oncology specialist Epizyme and its first-in-class, chemotherapy-free EZH2a inhibitor Tazverik, which is approved for third-line use in relapsed or refractory follicular lymphoma. The drug is also approved for patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection and is currently in a phase 3 confirmatory study in combination with Roche’s Rituxan and Bristol Myers Squibb’s Revlimid in patients with relapsed/refractory follicular lymphoma who have received at least one prior therapy. That study’s readout is pegged for 2026.