FDA Approves Onivyde for Metastatic Pancreatic Cancer

The approval was based on data from the phase 3 NAPOLI-1 trial, which demonstrated a 1.9-month improvement in overall survival (OS) with the addition of Onivyde to 5-FU and leucovorin.
SILAS INMAN @silasinman
PUBLISHED: OCTOBER 22, 2015
Talk about this article with other patients, caregivers, and advocates in the Pancreatic Cancer CURE discussion group.
The FDA has approved Onivyde (MM-398) in combination with 5-fluorouracil (5-FU) chemotherapy and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen.

The approval was based on data from the phase 3 NAPOLI-1 trial, which demonstrated a 1.9-month improvement in overall survival (OS) with the addition of Onivyde to 5-FU and leucovorin. In the combination arm, the median OS was 6.1 months compared with 4.2 months with 5-FU and leucovorin alone.

“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”

In the international trial, 417 patients with gemcitabine-refractory metastatic pancreatic cancer were randomized to Onivyde monotherapy, 5-FU with leucovorin (control), or Onivyde plus 5-FU and leucovorin. Per standard irinotecan protocols, dexamethasone and a 5-HT3 antagonist could be administered in the combination arms.

In the control, 5-FU was administered at 2,000 mg/m2 with racemic leucovorin at 200 mg/m2 weekly for four weeks followed by two weeks of rest (149 patients). In the combination arm, intravenous Onivyde was administered at 80 mg/m2 prior to 5-FU at 2400 mg/m2 and racemic leucovorin at 400 mg/m2 every two weeks (117 patients). In the monotherapy group, Onivyde was administered at 120 mg/m2 every three weeks (151 patients).

Altogether, 61 percent of patients had cancer in the head of the pancreas and 68 percent had liver metastases. A majority of the patients (83 percent) were enrolled outside of the U.S. In the combination arm, the median age of patients was 63 years, 64 percent were Caucasian, and 29 percent were Asian.

The median progression-free survival was 3.1 months for the combination compared with 1.5 months with the control. At 12 weeks, 57 percent of patients treated with the combination were alive and progression-free compared with 26 percent with 5-FU and leucovorin alone.

The objective response rate by RECIST v1.1 criteria was 16 percent versus 1 percent, for the combination and control, respectively. For those with baseline CA19-9 levels of greater than 30 U/ml at baseline (84 percent in the combination arm), there was at least a 50 percent reduction in the marker for 36 percent of patients treated with the combination versus 12 percent in the control arm.

In a subanalysis that assessed patients who received at least 80 percent of the target dose in the first six weeks, there was an even greater OS benefit with Onivyde. In this per-protocol population, treatment with Onivyde plus 5-FU/leucovorin (66 patients) improved OS by 53 percent compared with 5-FU/ leucovorin alone (71 patients). The median OS was 8.9 versus 5.1 months for the combination and 5-FU/ leucovorin, respectively.

Talk about this article with other patients, caregivers, and advocates in the Pancreatic Cancer CURE discussion group.
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