On December 9, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that data from the front-line triple negative breast cancer (TNBC) cohort from the ongoing MARIO-3 clinical trial was presented during the 2020 San Antonio Breast Cancer Symposium (SABCS) (Press release, Infinity Pharmaceuticals, DEC 9, 2020, View Source [SID1234572517]). MARIO-3 is the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination in the front-line setting with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in patients with unresectable locally advanced or metastatic TNBC.

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"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 Erika Hamilton, M.D., Program Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and MARIO-3 Lead Study Investigator. "The tumor reduction seen, irrespective of PD-L1 status, combined with eganelisib’s safety and tolerability profile, which demonstrated no new or additive safety signals, suggest that eganelisib has potential as a new treatment option for advanced TNBC patients."

Brian Schwartz, M.D., consulting Chief Physician of Infinity Pharmaceuticals, said, "We are particularly excited to report that the addition of eganelisib to treatment with atezolizumab and nab-paclitaxel has led to very encouraging overall response rates of 100% in PD-L1 positive patients and 50% in PD-L1 negative patients. This is important because, while the accelerated approval of combination therapy of atezolizumab and nab-paclitaxel as a front-line treatment for PD-L1 positive patients is an important step in addressing the severe unmet need in TNBC, this type of breast cancer remains an aggressive and difficult-to-treat disease, and more treatment options are needed particularly in PD-L1 negative setting. We also continue to be pleased by the safety and tolerability profile of the 30mg dose of eganelisib in multiple combinations including in MARIO-3. These data suggest that this novel triplet regimen may be broadly beneficial across patient populations in TNBC, including PD-L1 negative patients with limited treatment options and poor outcomes. In addition, the translational data from the study are highly consistent with prior results from MARIO-1, which together are supportive of the unique immune modulating activity of eganelisib across multiple indications. These strong, early data leave us increasingly confident in the potential of eganelisib in TNBC, and we look forward to continued progress and execution in the ongoing MARIO-3 study."

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 Erika Hamilton, M.D.

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 November 6th cut-off for the SABCS presentation 20 of 60 patients enrolled, and the 7 most recently enrolled patients remained on treatment but had not yet had their first assessment. Infinity expects to complete enrollment in MARIO-3 in mid-2021.

Earlier this year the U.S. Food and Drug Administration (FDA) granted Fast Track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions while fulfilling an unmet medical need, enabling drugs to reach patients more rapidly. A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters pertaining to the drug’s clinical development plan as well as eligibility for accelerated approval and priority review.

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.