–Encouraging one-year progression free survival
rates in MARIO-3 1L TNBC study regardless of PD-L1 status–
- 52% increase in one-year progression free
survival rate in ITT patient population compared to IMpassion130
benchmark -
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the
“Company”), a clinical-stage biotechnology company developing
eganelisib, a first-in-class, oral, immuno-oncology macrophage
reprogramming therapeutic, today reported an update from its
MARIO-3 study of eganelisib in combination with atezolizumab and
nab-paclitaxel in front-line metastatic triple negative breast
cancer (TNBC) patients.
“Given our goal of improving long-term patient outcomes, we are
particularly pleased to see that the addition of eganelisib to
standard of care therapy showed benefit in the one-year progression
free survival rate in MARIO-3 regardless of PD-L1 status,” said
Robert Ilaria, Jr., MD, Chief Medical Officer of Infinity. “These
data reinforce the positive two-year landmark overall survival data
from MARIO-275 in 2L urothelial cancer, also regardless of PD-L1
status, and the encouraging PFS observed in checkpoint inhibitor
refractory squamous cell cancer of the head and neck in our MARIO-1
study, which all support the potential of eganelisib to improve
long term outcomes for patients.”
MARIO-3 mTNBC Updated Data:
- 62 patients were enrolled and evaluable for safety, and 57
patients were evaluable for efficacy, with a median duration of
follow-up of 10.0 (8.1,14.2) months. Of the 57 evaluable patients:
- 35 patients (61.4%) had PD-L1(-) tumors
- 18 patients (31.6%) had PD-L1(+) tumors
- 4 patients (7.0%) had tumors of undetermined PD-L1 status
- With an additional year of data maturity since the San Antonio
Breast Cancer Symposium 2021, there is now encouraging evidence of
a long-term patient progression-free survival (PFS) benefit with
improved one-year PFS rates in MARIO-3, including in patients with
both PD-L1(+) and PD-L1(-) tumors, compared to the benchmark
IMpassion130 study.
ITT
PD-L1 (+)
PD-L1 (-)
MARIO-3
n=57^
IMpassion130
n=451^^
MARIO-3
n=18
IMpassion130
n=185
MARIO-3
n=35
IMpassion130
n=266
One-Year PFS Rate, % (95% CI)
36.0%
(23.7, 49.3)
23.7%
(19.6, 27.9)
37.5%
(16.8, 60.9)
29.1%
(22.2, 36.1)
34.7%
(19.6, 51.6)
NR*
One-Year PFS Rate improvement compared to
IMpassion130
52%
relative improvement
29%
relative improvement
NE**
[46% relative improvement
compared to IMpassion130 ITT]
Median duration of follow up, months (95%
CI)
10.0
(8.1, 14.2)
13.0
(NR*)
9.9
(5.5, NA)
NR*
9.3
(5.9, 14.2)
NR*
Data Snapshot: 8 October 2022
^4 patients of unknown PD-L1 status
^^ Schmid et al NEJM 2018
* NR = Not Reported
**NE = Not Evaluable
- Additional data from the MARIO-3 study, by patient population
and relative to IMpassion130 benchmarks:
PD-L1 (+)
PD-L1 (-)
MARIO-3
n=18
IMpassion130^
n=185
MARIO-3
n=35
IMpassion130^
n=265
CR, % (n)^^
16.7 (3)
10.3 (19)
5.7 (2)
4.9 (13)
ORR, % (n)^^
66.7 (12)
58.9 (109)
54.3 (19)
54.0 (143)
mDOR (mos) n (95% CI)^
11.7
n=12
(1.8, NA)
8.5
n=109
(7.3, 9.7)
7.4
n=19
(3.7, NA)
NR*
mDOR increase compared to IMpassion130
3.2 mos
(37.6% increase)
NE**
mPFS, mos
(95% CI)
6.4 (3.6, NA)
7.5 (6.7, 9.2)
7.3 (5.2, 13.3)
5.6 (5.5, 7.3)
Data Snapshot: 8 October 2022
^Schmid et al NEJM 2018 with PD-L1(-) data
calculated based on ITT and PD-L1(+) data
^^ Includes unconfirmed and confirmed
responses for MARIO-3
*NR = Not Reported
** NE = Not Evaluable
- No new safety signals were observed during the extended period
on treatment, and the MARIO-3 safety profile continued to be
consistent with expectations for the three component drugs.
- Most Common Treatment-Related TEAEs in ≥ 10% of All Treated
Patients^* (n=62)
Preferred Term/Grouped
Term
Treatment related TEAE (All),
n (%)
Treatment-related TEAE (≥ Gr.
3), n (%)
Fatigue
30 (48.4)
4 (6.5)
Skin AEs
29 (46.8)
7 (11.3)
Nausea
28 (45.2)
0 (0.0)
Hepatic AEs**
24 (38.7)
15 (24.2)
Diarrhea
18 (29.0)
3 (4.8)
Alopecia
16 (25.8)
0 (0.0)
Neutropenia AEs
16 (25.8)
9 (14.5)
Vomiting
13(21.0)
1 (1.6)
Pyrexia
10 (16.1)
0 (0.0)
Peripheral neuropathy
19 (30.6)
7 (11.3)
Stomatitis
9 (14.5)
0 (0.0)
Decreased appetite
8 (12.9)
0 (0.0)
Headache
8 (12.9)
0 (0.0)
Weight decreased
7 (11.3)
1 (1.6)
Dysgeusia
7 (11.3)
0 (0.0)
Constipation
7 (11.3)
0 (0.0)
Data Snapshot: 23 July 2022
Presented in descending order of All
Treatment-Related TEAE
^ Treatment-related is related to any of
the study drugs (eganelisib, atezolizumab, nab-paclitaxel)
* No treatment-related Grade 5 AEs
** One Grade 4 event and no event met Hy’s
Law criteria
Hepatic, skin, neutropenia, and peripheral
neuropathy represent grouped preferred terms.
- Treatment Discontinuation: 74% of patients were able to
remain on treatment with the MARIO-3 TNBC triplet regimen compared
to 81% of patients with the IMpassion130 doublet.
MARIO-3 Egan+
Atezo+Nab-Pac
IMpassion130*
Atezo+Nab-Pac
(n=62),
n (%)
(n=460),
n (%)
All-causality AEs
Any grade
61
(98.4)
457
(99.3)
Grade 3 or 4
41
(66.1)
233
(50.7)
Grade 5
5
(8.1)
6
(1.3)
Serious AEs
22
(35.5)
110
(23.9)
AE leading to any drug withdraw
16
(25.8)
88
(19.1)
AE leading to Atezo withdraw
14
(22.6)
37
(8.0)
AE leading to Nab-Pac withdraw
11
(17.7)
85
(18.5)
Treatment-related AEs**
Any grade
60
(96.8)
444
(96.5)
Grade 3 or 4
42
(67.7)
191
(41.5)
Grade 5
0
(0.0)
2
(0.4)
Serious AEs
9
(14.5)
58
(12.6)
Data Snapshot: 23 July 2022
* Emens et al., Annal of Oncology 2021
** MARIO-3 data listed are for TEAEs
related to any study drug
About Infinity and Eganelisib
Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is
a clinical-stage biotechnology company developing eganelisib
(IPI-549), a first-in-class, oral, immuno-oncology macrophage
reprogramming therapeutic which is designed to address a
fundamental biologic mechanism of immune suppression in cancer in
multiple clinical studies. 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. MARIO-275 is a randomized, controlled
combination study of eganelisib combined with Opdivo® in I/O naïve
urothelial cancer. 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 the Company’s
guidance with respect to the therapeutic potential of eganelisib
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 or
will be successful in establishing a strategic partnership to
further the development of eganelisib. 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:
results of clinical trials and preclinical studies, including
subsequent analysis of existing data and new data received from
ongoing and future studies; the cost, timing and results of
clinical trials; the content and timing of decisions made by the
U.S. FDA and other regulatory authorities; Infinity's ability to
obtain and maintain requisite regulatory approvals; unplanned cash
requirements and expenditures; development of agents by Infinity's
competitors for diseases in which Infinity is currently developing
or intends to develop eganelisib; and Infinity's ability to obtain,
maintain and enforce patent and other intellectual property
protection for eganelisib. These and other risks which may impact
management's expectations are described in greater detail under the
caption "Risk Factors" included in Infinity's annual report and
quarterly reports filed with the Securities and Exchange Commission
(SEC), and in other filings that Infinity makes with the SEC,
available through the Company’s website at www.infi.com. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Infinity does not undertake and
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of Genentech, Inc.
Abraxane® is a registered trademark of Abraxis BioScience, LLC.,
a wholly owned subsidiary of Bristol Myers Squibb Company.
Avastin® is a registered trademark of Genentech, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20221114005336/en/
Investor Relations: Luke Heagle Real Chemistry
lheagle@realchemistry.com
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