THIO Shows Lower Toxicity Than Standard Treatments in NSCLC Study

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

REFERENCES:

1. MAIA Biotechnology announces new updates from phase 2 trial of novel cancer treatment agent. News release. MAIA Biotechnology. July 23, 2024. Accessed July 24, 2024. https://tinyurl.com/msmhpswx

2. MAIA Biotechnology announces strong efficacy of THIO as third-line treatment for non-small cell lung cancer patients. News release. MAIA Biotechnology. March 6, 2024. Accessed July 24, 2024. https://tinyurl.com/2h2vdea5

3. MAIA Biotechnology reports positive topline data from part A safety lead-in of THIO-101 phase 2 trial for non-small cell lung cancer. News release. MAIA Biotechnology. April 11, 2023. Accessed July 24, 2024. https://bit.ly/43tO7ra

4. MAIA Biotechnology reports updates on preliminary survival data for THIO-101 phase 2 trial for advanced non-small cell lung cancer. News release. MAIA Biotechnology. July 10, 2023. Accessed July 24, 2024. https://tinyurl.com/4z5jj6ra

5. FDA grants orphan drug designation to MAIA Biotechnology for THIO as a treatment for gliolastoma. News release. MAIA Biotechnology. November 10, 2023. Accessed July 24, 2024. https://tinyurl.com/f7ur364p

6. MAIA biotechnology’s telomere-targeting agent THIO, in combination with checkpoint inhibitor immune therapies atezolizumab (anti-PD-L1) or pembrolizumab (anti-PD-1), demonstrated significantly greater tumor inhibition. News release. MAIA Biotechnology. February 13, 2023. Accessed July 24, 2024. https://bwnews.pr/3IqeUfz