A phase 3 study evaluating therapy as first-line treatment for patients with unresectable, locally advanced pancreatic cancer met its main goal of overall survival (OS).
Researchers from the phase 3 study, PANOVA-3, evaluated tumor-treating fields plus a chemotherapy regimen of gemcitabine and nab-paclitaxel, according to a news release from Novocure and Zai Lab, the manufacturers of the tumor-treating fields.
Tumor-treating fields use electrical fields with low energy to prevent cancer cells from growing and dividing, according to the American Cancer Society.
The study’s primary end point was overall survival, which was met after data demonstrated a statistically significant improvement in the median OS.
Glossary:
Unresectable: cancer that cannot be surgically removed.
Overall survival (OS): time patients live, regardless of their disease status, until death by any cause.
End point: goals measured at the end of a study to see if the treatment worked.
Progression-free survival (PFS): time patients live without their disease worsening or spreading.
Objective response rate: percentage of patients who have a partial or complete response to treatment, meaning their disease shrunk or completely disappeared.
Intravenously: treatment administered into the vein.
“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 end point of overall survival, a landmark outcome for this field,” Dr. Vincent Picozzi, medical oncologist at Virginia Mason Medical Center in Washington and investigator in the PANOVA-3 trial, said in the news release. “These data for tumor treating fields are very promising, especially in this difficult-to-treat patient population.”
Among patients who were treated with tumor-treating fields plus chemotherapy, the median OS was 16.2 months versus 14.16 months in patients who received chemotherapy alone, according to the news release. Patients treated with tumor-treating fields had an increased survival rate benefit over time, which was a 13% OS rate improvement at 12 months. At 24 months, the OS rate demonstrated a 33% improvement, as stated in the news release.
The study included 571 patients who were randomly assigned to either receive tumor-treating fields with the chemotherapy regimen or the chemotherapy regimen alone, as stated on the study’s clinicaltrials.gov listing.
Patients who received tumor-treating fields wore four electrically insulated electrode arrays on the torso, the listing noted. It also stated that patients who received this treatment could continue to maintain their daily routine.
All patients in the study received the same chemotherapy regimen, the clinicaltrials.gov listing showed. Patients received 125 milligrams (mg) per square meter of nab-paclitaxel intravenously for 30 to 40 minutes. After, patients were treated with 1,000 mg per square meter of gemcitabine for 30 minutes.
“PANOVA-3 is the first and only phase 3 trial to demonstrate a statistically significant benefit in OS specifically in unresectable, locally advanced pancreatic cancer,” Dr. Nicolas Leupin, chief medical Officer, Novocure, said in the news release.
Secondary end points in the study included progression-free survival (PFS), local PFS, objective response rate, one-year survival rate, pain-free survival, quality of life, puncture-free survival, resectability rate and toxicity.
Based on the findings from PANOVA-3, Novocure plans to file for regulatory approval of tumor-treating fields in patients with unresectable, locally advanced pancreatic cancer, the news release stated. Similarly, Zai Lab plans to file for regulatory approval in China for the same patient population.
“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,” said Dr. Rafael Amado, president, head of global research and development at Zai Lab, in the release. “Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement.”
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