Neon Therapeutics has treated the first patient in a Phase Ib clinical trial that aims to analyse NEO-PV-01 vaccine in combination with Keytruda (pembrolizumab) along with chemotherapy to treat patients with untreated or advanced metastatic nonsquamous non-small cell lung cancer (NSCLC).
Conducted in partnership with Merck, the trial seeks to investigate the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with Keytruda, as well as a chemotherapy regimen of pemetrexed and carboplatin.
The open-label trial will also examine neoantigen-specific immune responses in peripheral blood and tumour tissue, and other markers of immune response.
The trial expects to enrol a total of 15 patients and plans to expand enrolment.
As part of the trial, patients will undergo an initial biopsy and receive treatment with chemotherapy and Keytruda.
Neon will then manufacture a personal vaccine for each patient, depending upon an analysis of tumour neoantigen mutations.
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At week 12, patients will receive the NEO-PV-01 vaccine, along with Keytruda.
Neon Therapeutics research and development president Richard Gaynor said: “Treating our first patient in this clinical study marks an important milestone for Neon.
“We see a strong mechanistic rationale to explore the combination and sequence of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy.
“These data will help us understand the potential of NEO-PV-01 to improve durability and response rates of patients treated in combination with existing immuno-oncology drugs.”
NEO-PV-01 is currently under development by Neon Therapeutics as a personal cancer vaccine designed specifically for each patient based on DNA mutations from that patient’s tumour.