Survival Benefit With Onivyde Sustained in Updated Pancreatic Cancer Study Data

This study of Onivyde, 5-FU and leucovorin for the treatment of patients with metastatic pancreatic cancer was presented at the 2016 Gastrointestinal Cancers Symposium.
BY SILAS INMAN @silasinman
PUBLISHED: JANUARY 26, 2016
The addition of Onivyde (liposomal irinotecan; nal-IRI; MM-398) to 5-fluorouracil (5-FU) and leucovorin reduced the risk of death by 25 percent for patients with metastatic pancreatic cancer following progression on a gemcitabine-based regimen. These updated data from the phase 3 NAPOLI-1 trial were presented at the 2016 Gastrointestinal (GI) Cancers Symposium, a meeting of hundreds of oncologists and other oncology professionals in San Francisco in mid-January.1

In the updated analysis that was conducted after 91 percent of events, median overall survival (OS) with Onivyde, 5-FU, and leucovorin was 6.2 months compared with 4.2 months for 5-FU and leucovorin alone. After 12 months, 26 percent of patients treated with the Onivyde combination remained alive compared with 16 percent with 5-FU plus leucovorin alone. At approximately 20 months, survival was similar between the two groups.

“With a significant improvement in the 12-month overall survival rate and a well-defined safety and tolerability profile, the Onivyde combination regimen is well-positioned to become the standard of care in the post-gemcitabine setting,” lead investigator Andrea Wang-Gillam, from the Siteman Cancer Center and Washington University School of Medicine, St. Louis, said in a statement. “This new therapy offers hope for extended life expectancy in a patient population with limited options.”

In the international trial, 417 patients with gemcitabine-refractory metastatic pancreatic adenocarcinoma 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 2000 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 United States. In the combination arm, the median age of patients was 63 years, 64 percent were Caucasian and 29 percent were Asian.

In the primary analysis that was conducted after 83 percent events, median OS was 6.1 months with the Onivyde triplet compared with 4.2 months with 5-FU and leucovorin alone. The median progression-free survival was 3.1 months for the combination compared with 1.5 months with the control.

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