International journal of radiation oncology, biology, physics · 2026
NRG-GI007: Phase 1 Study of OBP-301, An Oncolytic Virus, and Definitive Chemoradiation in Locally Advanced Esophageal Cancer.
СтатьяНазвание и аннотация: Перевод в очереди
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Ku Geoffrey Y, Winter Kathryn, Ilson David, Adusumilli Prasad S, Nishimura Makoto, Yock Adam D, Mehta Rutika J, Biran Talia, Frakes Jessica M, Wu Abraham, Miller Eric David, Klempner Samuel J, Moughan Jennifer, Hong Theodore S, Williams Terence M
Аннотация
PURPOSE: Definitive chemoradiation (CRT) is standard for patients with medically inoperable esophageal cancer. OBP-301 is a modified adenovirus that adds a human telomerase reverse transcriptase gene promoter, replicating only in tumor cells to cause lysis.
METHODS AND MATERIALS: In this phase 1 study, OBP-301 was added to carboplatin/paclitaxel and radiation therapy (RT) (50.4 Gy). Patients received intratumoral OBP-301 via endoscopy 3 days prior to and then at days 12 and 26 of RT. The primary endpoint was protocol-defined dose-limiting toxicity. Secondary endpoints included clinical complete response (cCR) rate, number alive and alive without progression at 1 year.
RESULTS: From June 2020 to July 2024, 15 evaluable patients were enrolled. Fourteen patients (93%) received all planned OBP-301 injections and 50.4 Gy RT. No dose-limiting toxicities were observed. The most common treatment-related grade 3/4 toxicities were neutropenia (40%) and lymphopenia (33%). Two patients died prior to restaging: 1 patient developed grade 5 respiratory failure 6 weeks after CRT (suspected RT pneumonitis), whereas a second patient had unrecognized airway involvement at baseline, which led to a tracheoesophageal fistula during Week 3 of CRT. The cCR rate for patients undergoing restaging (n = 13) was 100% (95% CI, 77-100), and 87% (95% CI, 62-96) for all 15 patients. At 1 year, 9 (60%) out of 15 patients are still alive and 8 (53%) are alive without progression.
CONCLUSIONS: OBP-301 administration before and during CRT is feasible and safe, resulting in a very promising cCR rate. A randomized study is being planned to further evaluate safety and efficacy.
METHODS AND MATERIALS: In this phase 1 study, OBP-301 was added to carboplatin/paclitaxel and radiation therapy (RT) (50.4 Gy). Patients received intratumoral OBP-301 via endoscopy 3 days prior to and then at days 12 and 26 of RT. The primary endpoint was protocol-defined dose-limiting toxicity. Secondary endpoints included clinical complete response (cCR) rate, number alive and alive without progression at 1 year.
RESULTS: From June 2020 to July 2024, 15 evaluable patients were enrolled. Fourteen patients (93%) received all planned OBP-301 injections and 50.4 Gy RT. No dose-limiting toxicities were observed. The most common treatment-related grade 3/4 toxicities were neutropenia (40%) and lymphopenia (33%). Two patients died prior to restaging: 1 patient developed grade 5 respiratory failure 6 weeks after CRT (suspected RT pneumonitis), whereas a second patient had unrecognized airway involvement at baseline, which led to a tracheoesophageal fistula during Week 3 of CRT. The cCR rate for patients undergoing restaging (n = 13) was 100% (95% CI, 77-100), and 87% (95% CI, 62-96) for all 15 patients. At 1 year, 9 (60%) out of 15 patients are still alive and 8 (53%) are alive without progression.
CONCLUSIONS: OBP-301 administration before and during CRT is feasible and safe, resulting in a very promising cCR rate. A randomized study is being planned to further evaluate safety and efficacy.