Infinity Pharmaceuticals Provides Update for Eganelisib in Patients with Metastatic Urothelial Cancer
-Infinity Planning New, Registration-Enabling Study in Advanced Urothelial Cancer Leveraging Encouraging Data from MARIO-275-
-MARIO-275 Data to be Presented at a Major Medical Meeting in Q1 2021-
-Infinity Provides 2021 Milestones and Financial Guidance-
“The MARIO-275 study provided Infinity with important insights to shape the future of eganelisib in urothelial cancer,” said
Encouraging data including in post-CPI progression and PD-L1 low patients was presented at
Program Updates and Guidance:
- 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.
- 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
About Infinity and Eganelisib
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, placebo-controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-naïve, and front-line settings. For more information on Infinity, please refer to Infinity's website at www.infi.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding: the therapeutic potential of eganelisib; plans to present data; plans to not re-open MARIO-275 for enrollment; plans for a registration-enabling study in urothelial cancer; financial guidance; and the Company's ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that eganelisib will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the cost, timing and results of clinical trials and other development activities that may be delayed or disrupted by the COVID-19 pandemic or otherwise; the content and timing of decisions made by the
Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of
Abraxane® is a registered trademark of
Avastin® is a registered trademark of
Doxil® is a registered trademark of