On January 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported an update on MARIO-275, the Company’s randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O naïve patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting (Press release, Infinity Pharmaceuticals, JAN 6, 2021, View Source [SID1234573541]).

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"The MARIO-275 study provided Infinity with important insights to shape the future of eganelisib in urothelial cancer," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "The data from the 49 patients enrolled in the study are very encouraging. The combination was well tolerated at the 30 mg dose of eganelisib and provided patient benefit relative to the placebo controlled arm on important response rate and progression free survival measures, particularly in urothelial cancer patients with low levels of PD-L1 expression who respond poorly to checkpoint inhibitors alone. We are leveraging the clinical and translational learnings from MARIO-275 in planning a new, registration-enabling study of eganelisib in patients with advanced urothelial cancer. We look forward to presenting our data from MARIO-275, which support our clinical strategy, at a major medical meeting in Q1 2021, with details for our new, planned trial to follow in the coming months after discussions with regulatory authorities."

Encouraging data including in post-CPI progression and PD-L1 low patients was presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November and the San Antonio Breast Cancer Symposium (SABCS) in Q4 2020.

Program Updates and Guidance:

MARIO-275

The MARIO-275 Independent Data Monitoring Committee (IDMC) determined that there was a favorable risk/benefit for patients after the successful implementation of a dose reduction from 40mg QD to 30mg QD to reduce the reversible liver enzyme elevations that were reported after the first scheduled MARIO-275 IDMC meeting.
Infinity has completed the evaluation of the 49 patients enrolled in the study with encouraging safety, response rate and progression free survival (PFS) data, including in patients with low levels of PD-L1 expression.
Infinity will be presenting the MARIO-275 data at a major medical meeting in Q1 2021.
As a result of the encouraging data, the Company is planning a new registration-enabling study and will not re-open enrollment in MARIO-275.
MARIO-3

Data was presented at SABCS in December which showed the benefit of adding eganelisib to standard of care Tecentriq and Abraxane therapy for front-line TNBC patients.
Progression-free survival and updated overall response rate data for TNBC will be presented in 1H and 2H of 2021.
Renal cell carcinoma data to be presented in 1H 2022.
2021 Financial Guidance

Infinity ended 2020 with approximately $34.1 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2020 financial results in March. The Company expects to have cash through 2021 based on its current operating plans, which excludes additional financing or business activities, and excludes a potential $5 million milestone payment from BVF for positive Phase 3 patidegib data and any milestones from, or the sale of the Company’s equity interest in, PellePharm.