OBI Pharma, Inc. announced Adagloxad Simolenin (OBI-822)/OBI-821, receives a positive first interim analysis recommendation, suggestingthe continuation of the Phase III TNBC trial. Indication:
Adagloxad Simolenin (OBI-822) is a therapeutic cancer vaccine classified as an active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system. OBI-821 is an adjuvant that is mixed with OBI-822 to strengthen the immune response. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis):1st interim analysis of Adagloxad Simolenin (OBI-822)/OBI-821 TNBC (triple-negative breast cancer) Phase III clinical trial. A. Clinical Study Design: a. Protocol Title: The GLORIA Study: A Phase III, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Early Stage, High Risk, Globo H-Positive Triple Negative Breast Cancer; b. Study Purpose: To assess the efficacy and safety of Adagloxad Simolenin (OBI-822)/OBI-821; c. Phase of Clinical Study: Phase III clinical trial; d. Investigational product: The active cancer immunotherapy Adagloxad Simolenin (OBI-822)/OBI-821; e. Indication: Early stage, high risk, Globo H-Positive Triple Negative Breast Cancer; f. Endpoints: Primary endpoints: To determine the effect of Adagloxad Simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population. Secondary endpoints: To determine the impact of Adagloxad Simolenin (OBI-822)/OBI-821 treatment in the study population, on: -Overall survival (OS); -Quality of Life (QoL); -Breast cancer-free interval (BCFI); -Distant disease-free survival (DDFS); -To determine safety and tolerability of Adagloxad Simolenin (OBI-822)/OBI-821 in the study population; g. Number of subjects enrolled: 668 (target). Primary and secondary endpoints and the statistical results: a. The company?s Phase III clinical trial targeting patients with early stage, high risk, Globo H-Positive Triple Negative Breast Cancer is still in progress. This time, DSMB (Data and Safety Monitoring Board) recommendation is announced after their review of the first interim analysis data. The DSMB will not reveal data to OBI until the clinical trial completion. OBI remains blinded and will only announce DSMB?s recommendation. b. Based on the GLORIA study protocol, the first interim analysis is conducted at 40% of information fraction (estimated to be when 75 of the total 187 primary endpoint events occurred) to assess futility. The DSMB reviewed the interim analysis data, evaluated the patient?s risk-benefit, and provided a positive recommendation. After their recommendation, the company will continue the clinical trial according to the proposed timeline. C. The results of a single clinical trial (including the p value or whether there are statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development. The investors shall be careful in judgement and investment. Upcoming development plan: Adagloxad Simolenin (OBI-822)/OBI-821 TNBC phase III clinical trial (1)Estimated date of completion: The clinical trial enrollment is expected to be completed by the end of 2025, but the progress will be adjusted based on the actual recruitment. This is a Phase III clinical trial targeting patients with early stage, high risk, Globo H-Positive Triple; Negative Breast Cancer. The primary efficacy endpoints is invasive disease free survival (IDFS), defined as the time from the date of randomization to the date of first invasive disease recurrence (local, regional, or distant), the date of second primary invasive cancer (breast or not), or death from any cause, whichever occurs first. Assuming a treatment effect with a hazard ration (HR) of 0.66 in the final analysis, a total of 187 primary endpoint events will be required to detect a treatment difference with 80% power, based on a two-sided log-rank test with an overall type I error rate of 5%. Once it reaches the 187 primary events, it will trigger the condition to unblind the study. An interim analysis will be conducted at 40% and 60 % of information fraction (estimated to be when approximately 75 and 113 primary endpoint events occur) to assess futility. The company will remain blinded to study results until the final analysis. Interim analyses will be conducted by the contract research organization (CRO) assigned to the study, with the DSMB providing recommendations on the conclusion of the futility assessments.