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Zai Lab and Novocure have announced positive results from the Phase III PANOVA-3 clinical trial. The study, evaluating the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for pancreatic cancer, met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS).1
PANOVA-3 is a prospective, randomized open-label, controlled trial. In addition to the primary endpoint of OS, secondary endpoints include progression free survival, local progression free survival, and objective response rate. The study enrolled 571 patients, randomized 1:1, and were followed for a minimum of 18 months.
“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” Vincent Picozzi, MD, medical oncologist and investigator in the PANOVA-3 trial, said in a press release. “These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.”
According to study results, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, showing a statistically significant improvement.
“PANOVA-3 is the first and only Phase III trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase III clinical trial in the last two years,” Nicolas Leupin, MD, PhD, chief medical officer, Novocure, said in the press release. “We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.”
Additional results from the trial show survival rate benefit for patients treated with TTFields increased with a 13% improvement in OS at 12 months and a 33% improvement in survival rate at 24 months.
Rafael Amado, MD, president, head of global research and development at Zai Lab added, “There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in China, and this cancer is one of the most challenging to treat globally, with limited effective treatment options and poor survival outcomes. Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement. We are pleased to have been able to contribute to the PANOVA-3 study, and we look forward to working with Novocure to bring this therapy to patients as soon as possible.”
Based on results from the PANOVA-3 trial, Novocure will file for regulatory approval in the US, EU, Japan, and other key markets, while Zai Lab intends to file for approval in China.
Reference
1. Zai Lab and Novocure Announce Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer. News release. Zai Lab. December 2, 2024. Accessed December 2, 2024. https://www.businesswire.com/news/home/20241202363277/en/Zai-Lab-and-Novocure-Announce-Positive-Topline-Results-from-Phase-3-PANOVA-3-Clinical-Trial-of-Tumor-Treating-Fields-TTFields-Therapy-for-Pancreatic-Cancer