THIO-Libtayo Regimen Is ‘Encouraging’ for Relapsed NSCLC

A phase 2 trial evaluating a novel treatment regimen for patients with relapsed NSCLC is well-tolerated, researchers reported.

A regimen consisting of the novel drug THIO with Libtayo (cemiplimab) led to positive outcomes in patients with non-small cell lung cancer (NSCLC) that was previously treated with two or more standard-of-care options, according to findings from the phase 2 ongoing THIO-101 clinical trial.

Trial results were highlighted in a press release from MAIA Biotechnology, Inc., the manufacturer of THIO. Topline findings showed that six patients were still on treatment after 12 or more months. Additionally, THIO, followed by Libtayo, tended to be well-tolerated, “with much lower toxicity compared to standard-of-care treatments.”

According to the American Cancer Society, after NSCLC progresses or recurs on therapy, it could be treated in multiple ways. Smaller cancers that come back in the lungs can be treated with surgery or radiation, while cancer that comes back in the lymph nodes between the lungs may be treated with chemotherapy and potentially radiation. For disease that comes back in more distant parts of the body, clinicians may choose to prescribe chemotherapy, targeted therapy and/or immunotherapy.

“With current therapies, second-line patients’ treatment duration is usually around three to four months and third-line is even lower than that,” Dr. Vlad Vitoc, chairman and CEO of MAIA said in the press release.

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THIO works by targeting telomeres (protein sequences that protect the DNA replication process) found on cancer cells. These telomeres play a crucial role in the survival of cancer cells and their ability to evade or become resistant to other therapies, according to the release.

When THIO is followed by Libtayo, which is a checkpoint inhibitor that blocks the pathway that helps cancer cells hide from the immune system, it leads to “profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type-specific immune memory.”

“It is very encouraging to see that our patients can remain on treatment for much longer [than other therapies]. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options,” Vitoc said.

According to the study’s listing on ClinicalTrials.gov, researchers in the THIO-101 trial are analyzing the incidence of dose-limiting toxicities, safety and side effects from the sequenced THIO and Libtayo regimen.

Other main goals of the phase 2 trial include overall response rate (percentage of patients whose disease shrinks or disappears from therapy) as well as disease control rate (patients whose disease shrinks, disappears or stops growing after treatment). Other goals of the trial include duration of response (how long patients live with the therapy working), progression-free survival (time from treatment until disease worsening) and overall survival (time from treatment until death of any cause).

Per ClinicalTrials.gov, the estimated study completion date is in December of 2024.

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