- 12 of 15 (80%) patients completed the study and achieved the primary endpoint of at least a two-point reduction in the IgG4-RD Responder Index on Day 169 - - Eight patients achieved remission (IgG4-RD RI of zero) - - XmAb5871 well tolerated in patients with active IgG4-RD - [04-November-2017] MONROVIA, Calif., Nov. 4, 2017 /PRNewsw
- 12 of 15 (80%) patients completed the study and achieved the primary endpoint of at least a two-point reduction in the IgG4-RD Responder Index on Day 169 -
|
[04-November-2017] |
MONROVIA, Calif., Nov. 4, 2017 /PRNewswire/ -- Xencor (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced the final results from a Phase 2 study of XmAb5871 in patients with active IgG4-RD. Data show that 12 of 15 patients completed the study, and all 12 achieved the primary endpoint of at least a two-point reduction in the IgG4-RD Responder Index (IgG4-RD RI) on Day 169. The data are being presented by John H. Stone, M.D., MPH, director of rheumatology at Massachusetts General Hospital, at the American College of Rheumatology (ACR) 2017 Annual Meeting in the Late-breaking Abstract session on Tuesday, November 7, 2017 from 7:30 p.m. - 9:00 p.m. EST. “We are very encouraged by multiple clear signals of treatment benefit in this study - the achievement of the primary endpoint in all 12 patients that completed the study, the achievement of disease remission in more than 50% of patients, and the achievement of at least a five-point reduction in disease activity in 14 of 15 patients,” said Paul Foster, M.D., chief medical officer of Xencor. “We expect to advance development of XmAb5871 into a Phase 3 trial in the second half of 2018.” “The clinical response in IgG4-RD patients treated with XmAb5871 is very impressive and reinforces my belief that this is a promising potential therapy,” said Dr. John H. Stone, the principal investigator of the study. “We have learned a great deal about how to study this disease in the context of this trial.” Final Efficacy Data: Twelve of 15 patients (80%) completed the study and all 12 achieved the primary endpoint of at least a two-point reduction in the IgG4-RD RI on Day 169. None of the 12 required corticosteroids (CS) after month two. Eight patients achieved remission (IgG4-RD RI of 0 and no CS after two months) and the other four achieved IgG4-RD RI scores of ≤4 at Day 169. Fourteen of 15 patients (93%) achieved a decrease of ≥ 5 in the IgG4-RD RI. One patient had been on baseline CS for two years (15 mg/day) and was able to discontinue CS within two months. Four others received CS at the start of the trial and tapered off within two months. Safety and Tolerability Data: XmAb5871 was well tolerated. Three patients had minor, transient GI side-effects during the first infusion; all completed the study. Two serious adverse events (SAEs) unrelated to XmAb5871 were observed in one patient, pneumonia and recurrence of pneumonia due to non-compliance (patient completed study). Three patients discontinued the study, as disclosed previously. One discontinued patient was atypical with laryngeal involvement only who did not respond to XmAb5871 or to subsequent rituximab. A second patient responded, but flared at 12 weeks and did not respond to subsequent rituximab therapy. The third patient responded but developed infusion-related symptoms including transient rash and arthralgias following the fifth infusion. Plasmablasts were reduced 70-80% from baseline and B cells were reduced 40-55% from baseline, with decreases occurring within the first two weeks. The presentation will be available on the ‘Investors’ page of Xencor’s website under ‘Events and Presentations’ at www.xencor.com. Based on these results, Xencor plans to initiate a Phase 3 trial of XmAb5871 in IgG4-RD in 2H18. About the Clinical Trial Fifteen patients were enrolled in the study, having a median IgG4-RD RI of 12 (range 2-30) with active inflammatory disease in a median of five organ systems (1-10). The organs most commonly affected were lymph nodes (73% of patients), submandibular glands (60%), parotid glands (53%), and lacrimal glands (47%). Five patients (33%) had kidney involvement, four (27%) had lung findings and three each (20%) had orbital lesions, nasal cavity involvement or heart/pericardium findings. Conference Call and Webcast: Xencor will host a conference call Tuesday, November 7, 2017 at 4:30 p.m. ET (1:30 p.m. PT) to discuss third quarter 2017 financial results and recent corporate updates, including the final results from its Phase 2 study of XmAb5871 in IgG4-RD. The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number: 99272433. A live webcast of the conference call will be available online from the investor relations section of the company’s website at www.xencor.com. The webcast will be archived on the company’s website for 30 days. About XmAb®5871 About IgG4-Related Disease About Xencor’s XmAb® Immune Inhibitor Technology About Xencor, Inc. Forward Looking Statements:
View original content with multimedia:http://www.prnewswire.com/news-releases/xencor-presents-final-results-from-phase-2-study-of-xmab5871-in-igg4-related-disease-igg4-rd-at-the-american-college-of-rheumatology-2017-annual-meeting-300549677.html SOURCE Xencor, Inc. | ||
Company Codes: NASDAQ-NMS:XNCR |