TG4010 immunotherapy plus first-line chemotherapy appeared to improve progression-free survival compared with placebo plus chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), a study published in the journal The Lancet Oncology has shown.1
The findings of this study are particularly encouraging considering that a phase 2 trial evaluating TG4010 in patients with adenocarcinoma of the prostate was terminated nearly a decade ago.
“The TIME trial results published today support the further development of TG4010 for the treatment of advanced non-small cell lung cancer,” said lead author Elisabeth Quoix, MD, head of the Department of Pulmonology at the University Hospital of Strasbourg in France, and coordinating investigator of the TIME study.2
She emailed Cancer Therapy Advisor that the most important findings were the progression-free survival benefit and the survival benefit obtained for patients, especially adenocarcinoma patients with CD16, CD56, and CD69 triple-positive activated lymphocytes (TrPAL) values in the 3 lowest quartiles.
For the double-blind, placebo-controlled, phase 2b/3 TIME trial, researchers enrolled 222 previously untreated patients with stage 4 NSCLC without a known activating EGFR mutation and with MUC1 expression in at least half of tumoral cells.1
Participants were randomly assigned 1:1 to receive subcutaneous injections of 108 plaque-forming units of TG4010 or placebo from the initiation of chemotherapy every week for 6 weeks, then every 3 weeks until disease progression, unacceptable toxicity, or discontinuation for any reason.
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The study demonstrated that patients who received TG4010 had a median progression-free survival of 5.9 months (95% CI, 5.4 – 6.7) vs 5.1 months (95% CI, 4.2 – 5.9) for patients who received placebo plus chemotherapy (HR, 0.74; 95% CI, 0.55 – 0.98; P = .019). The platinum-based doublets used were cisplatin-gemcitabine, carboplatin-paclitaxel, and cisplatin-pemetrexed.