MACK - Ipsen Onivyde fails to improve overall survival of lung cancer patients in phase 3 trial

Ipsen's ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) pancreatic cancer drug Onivyde did not meet the main goal of overall survival (OS) versus Novartis' ( NVS ) Hycamtin (topotecan) in a phase 3 trial in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy.

The study, dubbed RESILIENT, was conducted in two parts: the first part results were reported in 2020 confirming the safety, dosing and efficacy of Onivyde; while the second part was evaluating the efficacy of Onivyde versus topotecan, the company said in an Aug. 3 press release.

The French drugmaker, however, added that a doubling of objective response rate (ORR), a secondary goal, in favor of Onivyde was seen.

The safety and tolerability of Onivyde was consistent with its known profile, and no new safety concerns emerged, the company noted.

Ipsen said the study results will be communicated with the regulatory agency.

Ipsen added that it continue to explore the potential of Onivyde in other areas, and final data from a phase 3 trial, dubbed NAPOLI-3, in first-line pancreatic ductal adenocarcinoma is expected in H2 2022.

Onivyde, in combination with fluorouracil (5-FU) and leucovorin, is approved in the U.S. and Europe to treat certain patients with adenocarcinoma of the pancreas.

Ipsen had acquired rights to Onivyde from Merrimack Pharmaceuticals ( MACK ).

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