After collecting an FDA approval earlier this year for local pancreatic cancer, Novocure is putting forward positive clinical data for its electric field-based treatment in metastatic cases of the aggressive disease.
A phase 2 trial evaluated the company’s wearable device in a first-line approach for metastatic pancreatic ductal adenocarcinoma, alongside a drug regimen adding Genentech’s Tecentriq to a combination of gemcitabine and nab-paclitaxel.
Known as PANOVA-4, the study of 78 treated patients posted a disease control rate of about 74%—counting participants with solid tumors considered to be stable for at least 16 weeks, as well as those who showed partial or complete responses to the full therapy.
The results were a statistically significant improvement over a historical control group derived from a phase 3 trial of 431 patients who received the standard course of albumin-bound paclitaxel and gemcitabine chemotherapies alone. That cohort had posted a disease control rate of 48%, according to Novocure.
In addition, median overall survival reached 9.7 months, compared to 8.5 months in the control group from the 2013 trial, known as MPACT. The overall response rate amounted to 34.6%, with a median Novocure therapy duration of 25.6 weeks plus a median regimen of six cycles of Tecentriq, gemcitabine and nab-paclitaxel. Novocure said it plans to present additional PANOVA-4 data at a future scientific meeting.
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The FDA approved Novocure’s system for locally advanced pancreatic cancer, commercially known as Optune Pax, in February. Also given alongside gemcitabine and nab-paclitaxel, the portable device’s high-frequency electric fields aim to disrupt the physical reproduction of tumor cells as they divide and grow.
The company’s randomized, phase 3 PANOVA-3 trial followed a total of 571 patients for at least 18 months, demonstrating a median overall survival of 16.2 months in an intent-to-treat population, compared to 14.2 months among those receiving chemotherapy alone.
In a group receiving a modified protocol—including at least 28 days of Optune Pax therapy and at least one complete chemotherapy cycle—median overall survival increased to 18.3 months versus 15.1 months, for a 3.2 month gain. The study also measured a median time to pain progression of 15.2 months, compared to 9.1 months in the control.
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Novocure’s Tumor Treating Fields therapies have also been greenlit by the FDA to treat mesothelioma and glioblastoma.
Tecentriq has not yet been approved in pancreatic cancer, but the PD-L1 immunotherapy carries indications in melanoma and certain tumors of the lung, liver and bladder.
