Improvements in progression-free survival were particularly noticeable in patients with CD16, CD56, CD69 TrPAL values of less than or equal to the upper limit of normal who had received immunotherapy compared with placebo (HR, 0.75; 95% CI, 0.54 – 1.03), as well as patients with both low TrPAL and non-squamous NSCLC.

In terms of safety, grade 1 to 2 injection site reactions occurred in 33% of patients who received TG4010 compared with 4% in the placebo arm. Researchers determined that no grade 3 or 4 or serious adverse events were attributable to TG4010 only; however, 4% of patients experienced grade 3 or 4 adverse events deemed to be related to TG4010 and other study treatments vs 10% in the placebo plus chemotherapy arm. The most commonly reported grade 3 to 5 adverse events were neutropenia (38% with TG4010 vs 31% with placebo), anemia (11% vs 15%), and fatigue (12% vs 12%).


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“There is an urgent need for new lung cancer treatments, and immunotherapies are an area of great promise. It is important to continue to advance new treatments, particularly in combination with other therapies, and I look forward to the further development of TG4010 with chemotherapy, as well as with immune checkpoint inhibitors, in this important indication,” Dr Quoix said.2

TG4010 is a modified vaccinia Ankara (an attenuated vaccine of a poxvirus) expressing interleukin 2 and MUC1, a tumor-associated antigen expressed by many solid tumors, including breast, colorectal, kidney, lung, and prostate cancers. It is designed to help the body’s immune system identify cancerous cells carrying highly immunogenic tumor associated antigen transformed from MUC1 so they can be destroyed.

Reference

  1. Quoix E, Lena H, Losonczy G, et al. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial [published online ahead of print December 22, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00483-0.
  2. Transgene announces publication in “The Lancet Oncology” of phase 2b TIME trial results with TG4010 immunotherapy in non-small cell lung cancer [news release]. Strasbourg, France; Transgene; December 23, 2015. http://www.transgene.fr/wp-content/uploads/2015/12/20151223_TIME-Ph2b-Lancet-Oncology-2015_PR-EN.pdf. Accessed February 8, 2016.