Glossary
Overall survival (OS): the length of time a patient lives after being diagnosed with cancer.
Overall response rate (ORR): the percentage of patients who experience a partial or complete response to a cancer treatment.
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THIO and Libtayo Extends OS in NSCLC Following Progression on SOC Therapy
Key Takeaways
- THIO, a first-in-class agent, targets telomeres, inducing cancer cell death and activating immune responses in NSCLC.
- The THIO-101 trial showed a median overall survival of 16.9 months, surpassing standard chemotherapy outcomes.
THIO sequenced with Libtayo extended overall survival in those with non–small cell lung cancer who progressed on two or more standard-of-care regimens.
THIO sequenced with Libtayo extended OS in NSCLC following progression. | © steph photographies - stock.adobe.com
Treatment with the lead clinical candidate THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) sequenced with the checkpoint inhibitor Libtayo (cemiplimab) extended overall survival (OS) in patients with advanced non–small cell lung cancer (NSCLC) who progressed on two or more standard-of-care therapy regimens, according to updated data from the pivotal phase 2 THIO-101 clinical trial which were shared in a press release from MAIA Biotechnology, Inc.
The third-line data showed a median OS of 16.9 months as of Jan. 15, 2025, in patients with NSCLC (22 patients) who were treated with at least one dose of THIO; these were patients in the intent-to- treat population who were included in parts A and B of the trial. This demonstrated an improvement in OS compared with the five-to-six-month OS that has been observed with standard-of-care chemotherapy treatments in NSCLC in a similar setting.
“Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin,” Dr. Vlad Vitoc, chief executive officer of MAIA, said in the press release. “THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in third-line 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 company believes that, based on the regulatory strategy, there may be an opportunity for an accelerated Food and Drug Administration (FDA) approval for treatment with THIO, pending final results from the ongoing expansion of the THIO-101 trial, according to the press release.
More on The Investigative Agent and Phase 2 Trial
THIO is a first-in-class investigational agent which was designed to target telomeres, which are critical for cancer cell survival and resistance to existing therapies. Telomeres, in conjunction with the enzyme telomerase, allow cancer cells to maintain their proliferative capacity. However, THIO is a modified nucleotide that induces telomerase-dependent alterations in telomeric DNA, triggering DNA damage responses and leading to selective cancer cell death. Additionally, THIO-damaged telomeric fragments accumulate in cytosolic micronuclei, activating both innate and adaptive immune responses.
According to previous research, preclinical studies have demonstrated that sequential treatment with THIO, followed by PD-(L)1 inhibitors, leads to profound and sustained tumor regression in advanced cancer models. This effect is attributed to the induction of cancer-specific immune memory. Based upon these previous findings, THIO is being developed as a second-line or later treatment for individuals with NSCLC whose disease no longer response to the standard-of-care checkpoint inhibitor therapies.
In order to evaluate the investigative agent, THIO-101, a multicenter, open-label, dose-finding clinical trial, was designed to evaluate the agent's anti-tumor activity in combination with PD-(L)1 inhibition. The investigation will determine whether administering low doses of THIO prior to Libtayo can enhance and prolong the immune response in patients with advanced NSCLC. This study focuses on patients who previously did not respond to or developed resistance to first-line checkpoint inhibitor therapy.
The co-primary objectives of the study are to assess the safety and tolerability of THIO as both an anticancer agent and an immune system priming activator, as well as to evaluate its clinical efficacy, using the overall response rate as the primary end point.
Treatment with THIO followed by Libtayo has been well tolerated in a heavily pre-treated patient population thus far.
Vitoc concluded by stating, “With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever.”
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