Infinity Pharmaceuticals Inc. Reports New Results From Phase 1 Study Of Investigational Oncology Compound Duvelisib At The American Society of Hematology Annual Meeting

SAN FRANCISCO--(BUSINESS WIRE)--Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported updated data from a Phase 1 monotherapy study of duvelisib (IPI-145), an inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, which showed activity among patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL), a fatal type of blood cancer. In the study, duvelisib demonstrated an overall response rate of 72 percent, including a 33 percent complete response rate, among 18 patients with iNHL who received the dose administered in ongoing registration-focused studies. In a separate presentation, updated Phase 1 data were also reported showing the activity of duvelisib in patients with relapsed/refractory T-cell lymphoma. These data were presented today at the 56^th Annual Meeting of the American Society of Hematology (ASH).

“Duvelisib (IPI-145), a phosphoinositide-3-kinase-delta,gamma inhibitor, shows activity in patients with relapsed/refractory T-cell lymphoma.”

“It is encouraging to see a high monotherapy response rate reported in these heavily pretreated patients with indolent non-Hodgkin lymphoma,” commented Ian Flinn, M.D., Ph.D., director, hematologic malignancies program, Sarah Cannon Research Institute, and an investigator for the trial. “While we have made some advances in the treatment of indolent lymphoma, additional therapies are needed, and these data suggest that duvelisib has potential as an important new option for some of these patients.”

Phase 1 Study Shows Activity in Patients with iNHL (Abstract #802)

Updated Phase 1 data in patients with relapsed/refractory iNHL were reported in an oral presentation, “A Phase 1 evaluation of duvelisib (IPI-145), a PI3K-delta,gamma inhibitor, in patients with relapsed/refractory iNHL.” The study included 34 patients evaluable for response, of which 18 received duvelisib dosed at 25 mg twice daily (BID), which is the dose being administered in ongoing registration-focused studies, DYNAMO^TM and DYNAMO+R.

Data showed that duvelisib administered at 25 mg BID was clinically active, with a 72 percent overall response rate (13 of 18 evaluable patients) and a 33 percent complete response rate (6 of 18 evaluable patients). Among patients with follicular lymphoma, the overall response rate was 69 percent (9 of 13 evaluable patients), including a 38 percent complete response rate (5 of 13 evaluable patients). The median progression free survival and median overall survival have not yet been reached, with 69 percent progression-free and 89 percent overall survival at 24 months.

At the 25 mg BID dose, the most common Grade 3 side effects were increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (32 percent), diarrhea (16 percent), neutropenia and pneumonia (11 percent each). Grade 4 neutropenia was 11 percent (2 patients), Grade 4 ALT or AST increase was 5 percent (1 patient) and Grade 4 pneumonia was 5 percent (1 patient). There were no Grade 4 events of diarrhea.

Phase 1 Trial Results Show Response in T-Cell Lymphoma (Abstract #803)

Infinity also reported Phase 1 data showing the activity of duvelisib in patients with T-cell lymphoma, which accounts for approximately 15 percent of all non-Hodgkin lymphomas in the U.S.

Treatment with duvelisib in heavily pre-treated patients with relapsed/refractory T-cell lymphoma led to an overall response rate of 42 percent (14 of 33 patients evaluable for response), including 2 complete responses and 12 partial responses. Among the 15 patients with peripheral T-cell lymphoma (PTCL) who were evaluable for response, duvelisib led to 2 complete responses and 6 partial responses, for an overall response rate of 53 percent. Among the 18 patients with cutaneous T-cell lymphoma (CTCL) evaluable for response, duvelisib led to 6 partial responses, for an overall response rate of 33 percent. Stable disease was observed in 1 patient with PTCL and 6 patients with CTCL.

“Though there has been recent progress in the treatment of T-cell lymphoma, there is still a tremendous need for new therapeutic options for patients with relapsed/refractory T-cell lymphoma. The responses observed in this study are encouraging and highlight the potentially broad activity of duvelisib for these patients,” stated Dr. Steven Horwitz, assistant attending in the department of medicine at Memorial Sloan-Kettering Cancer Center and an investigator for the trial.

The Grade 3 side effects in patients with T-cell lymphoma included increases in ALT or AST (31 percent, 11 patients), rash (17 percent, 6 patients) and pneumonia (14 percent, 5 patients). Two patients (6 percent) had Grade 4 ALT or AST increases and 1 patient (3 percent) had Grade 4 pneumonia. The majority of patients (27 of 35) received duvelisib dosed at 75 mg BID.

These data were reported in an oral presentation, “Duvelisib (IPI-145), a phosphoinositide-3-kinase-delta,gamma inhibitor, shows activity in patients with relapsed/refractory T-cell lymphoma.”

About Duvelisib

Duvelisib is an investigational inhibitor of Class I phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie Inc. The PI3K pathway is known to play a critical role in regulating the growth and survival of certain types of blood cancers. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. The investigational agent is being evaluated in registration-focused studies, including DYNAMO^TM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUO^TM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company’s website at www.infi.com.

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 Company’s expectations about: its ability to execute on its strategic plans and the therapeutic potential of PI3K inhibition and duvelisib. 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 Infinity will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that Infinity’s strategic collaboration with AbbVie will continue or 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: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2014, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.