THIO Shows Lower Toxicity Than Standard Treatments in NSCLC Study
A phase 2 trial shows that THIO, a new investigational drug, combined with cemiplimab, may be an effective and well-tolerated treatment for patients with advanced non–small cell lung cancer who have exhausted other options.
Illustration of lungs, medical concept: © yodiyim - stock.adobe.com
THIO (6-thio-2’-deoxyguanosine), a first-in-class investigational telomere-targeting agent, plus the checkpoint inhibitor cemiplimab (Libtayo), has continued to show tolerability and lower toxicity than standard-of-care (SOC) treatments in patients with advanced non–small cell lung cancer (NSCLC) who failed 2 or more therapies, according to updated findings from the phase 2 THIO-101 study (NCT05208944).1
Following at least 12 months of therapy, a total of 6 patients have remained on the treatment protocol of 180 mg of THIO given at 60 mg on days 1, 2, and 3 followed by 350 mg cemiplimab on day 5, repeated in 3-week cycles. One patient has completed 21 cycles of treatment.
MAIA Biotechnology, manufacturer of THIO, reports that the treatment has been well-tolerated and demonstrates lower rates of toxicity compared with SOC therapies.
“With current therapies, second-line patients’ treatment duration is usually around 3 to 4 months, and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for [patients with] advanced NSCLC faced with limited options,” said Vlad Vitoc, MD, chairman and chief executive officer of MAIA Biotechnology, in a press release.
Previously, in March 2024, MAIA Biotechnology reported an overall response rate (ORR) of 38% (n = 3) in the intent-to-treat population, which exceeds the ORR seen with SOC in patients without a targetable mutation.2
In April 2023, topline safety data was reported from THIO-101 and showed that patients treated with the sequential combination had mild toxicities, including grade 1 fatigue and muscle pain. There was 1 case of grade 3 nausea observed. However, no grade 4 AEs were reported.3
Then, in July 2023, it was reported that 2 patients remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any new anticancer treatment.4 Both patients had advanced stage IV metastatic disease and had failed 2 previous lines of therapy, including 1 line with an immune checkpoint inhibitor, and platinum-based chemotherapy.
THIO has also shown promise in preclinical studies as a treatment for glioblastoma. In November 2023, the FDA granted orphan drug designation to the agent in this disease state.5 In 2022, THIO was also granted orphan drug designations from the FDA in hepatocellular carcinoma and small cell lung cancer.6
