A treatment for patients living with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care (SOC) options could extend overall survival (OS) to 16.9 months according to updated results from MAIA Biotechnology’s Phase II trial.
The Chicago-based company has announced updated data from its THIO-101 pivotal Phase II trial (NCT05208944) examining its lead candidate, THIO (6-thio-2′-deoxyguanosine), an investigational telomere-targeting agent sequenced in combination with Regeneron’s Libtayo (cemiplimab), a programmed cell death protein 1 (PD-1) inhibitor. Libtayo was approved by the US Food and Drug Administration (FDA) as a first-line (1L) therapy for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression.
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On World Cancer Day (4 February), MAIA announced the multicentre, open-label trial saw a median OS of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO as a third-line (3L) therapy. The results come as an update to earlier results announced in June 2024 that a disease control rate (DCR) of 85% from THIO and Libtayo.
Vlad Vitoc, CEO of MAIA, said: “Treatment with THIO now shows a 99% probability that OS will extend past chemotherapy’s measure by a wide margin.
“THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in 3L treatment where the cancer is typically even more resistant to therapy. Our findings suggest great benefits to patients with unmet medical needs who see little hope for the future.”
The primary endpoints of the trial were safety and tolerability of THIO as an anticancer drug and priming immune activator, alongside clinical efficacy demonstrated in the form of overall response rate (ORR). The company met both of those endpoints in initial results from the Phase II trial, announced in March 2024 with an ORR of 38%.
The company added that sequential treatment with THIO followed by PD-1/PD-L1 inhibitors resulted in sustained tumour regression in advanced in vivo cancer models. Now, the company is looking to parse its success into approval before the US Food and Drug Administration (FDA).
A report published by GlobalData in October of last year found that across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan), revenue from NSCLC treatments is expected to see a significant expansion from 2022’s $25.2bn to 2032’s $63.5bn, expedited by more than 40 pipeline treatments currently in trials.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of NSCLC treatments, Johnson & Johnson (J&J) has reported positive topline outcomes from the Phase III MARIPOSA trial of Rybrevant (amivantamab). Meanwhile, the FDA has granted breakthrough therapy designation to Daiichi Sankyo for its antibody-drug conjugate (ADC) datopotamab deruxtecan.
