Infinity Pharmaceuticals Presents Front-Line Triple Negative Breast Cancer Data from Ongoing Phase 2 MARIO-3 Trial at the 2020 San Antonio Breast Cancer Symposium
- 100% of Evaluable Patients Achieved Tumor Reduction Irrespective of PD-L1 Status -
- 69.2% of Evaluable Patients Achieved Best Responses of Complete Response or Partial Response -
- Safety Consistent With Expectations Of Component Drugs -
- Conference Call Scheduled for
“These promising initial data suggest that the addition of eganelisib to atezolizumab and nab-paclitaxel has the potential to provide improved patient outcomes in front-line triple negative breast cancer,” said
Key presentation highlights:
Poster presentation titled, “MARIO-3 phase II study initial data evaluating a novel triplet combination of eganelisib (IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer (TNBC)” presented by
- 100% of evaluable patients (n=13) demonstrated tumor reduction
- 69.2% (9/13) overall response rate (ORR) with best responses of complete response (CR) or partial response (PR)
- 100% (5/5) ORR (CR + PR) with 1 CR and 4 PRs observed in PD-L1 positive patients
- 50% (4/8) ORR (CR + PR) with 4 PRs observed in PD-L1 negative patients
- Translational data are supportive of eganelisib’s immune modulation mechanism with treatment associated with decreased M2 macrophages and myeloid derived suppressor cells (MDSCs) and increased T cell reinvigoration as measured in peripheral blood.
- The novel triple combination treatment with eganelisib, atezolizumab (atezo) and nab-paclitaxel (nab-pac) demonstrated safety in line with expectations of the component drugs with no additive or new safety signals. The most common ≥ Grade 3 treatment-emergent adverse events were decreased neutrophil count (21.4 percent), diarrhea (14.3 percent), and rash (14.3 percent). Only one patient (7.1 percent) experienced ≥ Grade 3 ALT/AST increase, and this patient had a Grade 3 elevation.
Enrollment is ongoing. As of the
Earlier this year the
Eganelisib SABCS 2020 Poster Links:
Infinity MARIO-3 SABCS 2020 Poster: MARIO-3 phase II study initial data evaluating a novel triplet combination of eganelisib (IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer (TNBC)
Arcus ARC-2 SABCS 2020 Poster: ARC-2: Efficacy and Safety of Etrumadenant (AB928) + Pegylated Liposomal Doxorubicin (PLD) ± Eganelisib (IPI-549) in Participants with Metastatic Ovarian and Triple Negative Breast Cancer
Conference Call Information
A live webcast of the conference call with synchronized slides can be accessed in the "Investors/Media" section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2088322. An archived version of the webcast will be available on Infinity's website for 30 days.
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, 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 (AB928, a dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating eganelisib as a monotherapy and in combination with Opdivo (nivolumab) in patients with advanced solid tumors including patients refractory to checkpoint inhibitor therapy. 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; clinical trial enrollment projections; 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 outcome of the Company’s risk/benefit review of its MARIO-275 clinical trial; the content and timing of decisions made by the
Tecentriq® is a registered trademark of
Avastin® is a registered trademark of
Abraxane® is a registered trademark of
Opdivo® is a registered trademark of Bristol Myers Squibb.
Doxil® is a registered trademark of