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Idera Pharmaceuticals Presents Data from the ILLUMINATE-204 Trial of the Combination of Tilsotolimod and Ipilimumab for Unresectable or Metastatic Melanoma Following Failure of PD-1 Inhibitor Treatment at the 2018 European Society for Medical Oncolog | ||
By: Nasdaq / GlobeNewswire - 19 Oct 2018 | Back to overview list |
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- Key findings presented in poster discussion demonstrate clear abscopal effect of intratumoral tilsotolimod - - Data demonstrate contribution of tilsotolimod to overcome resistance to ipilimumab in patients with low HLA-ABC expression - - Company plans to provide additional clinical safety and efficacy data for up to 35 patients during the 4th quarter - EXTON, Pa., Oct. 19, 2018 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs, today presented data from the ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera’s intratumorally-delivered toll-like receptor 9 (TLR9) agonist, in combination with ipilimumab (Yervoy®*) at the 2018 European Society for Medical Oncology (ESMO) Congress. The poster, which was selected for a poster discussion session, highlighted additional analyses of data for 21 patients for whom efficacy and safety analysis were originally presented at the 2018 American Society of Clinical Oncology Annual Meeting this past June (data cut-off May 9th). The new analyses address the potential of intramural tilsotolimod to induce an antitumor response in combination with ipilimumab in injected tumors as well as uninjected tumors via an abscopal effect. As previously reported the overall response rate (ORR, by RECIST 1.1) for these 21 patients was 39%. Notably, in 7 of the 8 responders tumor shrinkage was observed in both the injected and uninjected tumors. Tumor shrinkage at uninjected lesions was observed in an additional four patients who had not met the criteria for RECIST v.1.1 response status as of this analysis. Clinical responses were seen in patients whose HLA-ABC RNA (MHC class I) expression is low at baseline. Rodig and colleagues1 have recently shown that robust MHC class I expression is required for anti-CTLA-4 activity. Our findings suggest that combining tilsotolimod with ipilimumab may overcome this resistance mechanism, and therefore, enhance clinical activity and increase the overall response rate compared to that expected with ipilimumab monotherapy. The ILLUMINATE-204 trial is enrolling two distinct patient populations, both patients who are naïve to ipilimumab therapy (N=40; Primary Efficacy Endpoint Population) and patients who have prior ipilimumab experience (N=Up to 20; Secondary Efficacy Endpoint Population). Of the initial 21 patients available for efficacy evaluations 6 of 17 patients from the Primary Efficacy Endpoint Population and 2 of 4 patients from the Secondary Efficacy Endpoint Population achieved RECIST v.1.1 responses, further demonstrating a signal that tilsotolimod has the potential to help overcome prior ipilimumab resistance. “The data presented at ESMO demonstrate that in patients with melanoma progressing on or after PD-1 inhibitor therapy, injecting a single tumor lesion with tilsotolimod, in combination with ipilimumab, produced tumor shrinkage in distant uninjected lesions in nearly all patients with reported responses by RECIST v1.1 criteria,” stated Adi Diab, M.D., Lead Trial Investigator, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. “Moreover, clinical responses were seen in tumors where MHC class I expression was low at baseline. In a recent clinical study in melanoma, it was shown that robust MHC class I expression is required for anti-CTLA-4 activity. Our findings suggest that combining tilsotolimod with ipilimumab may overcome this mechanism of resistance to anti-CTLA-4 monotherapy.” “The clear demonstration of tumor shrinkage in uninjected tumors following the injection of a single tumor lesion with tilsotolimod, provides clinical confirmation of our translational data and addresses an important frequently asked question,” stated Joanna Horobin, Idera’s Chief Medical Officer. “Additionally, the new observation that tilsotolimod may overcome the requirement for MHC class 1 expression for effective anti-tumor therapy with ipilimumab in patients otherwise unlikely to respond, is a very exciting finding and addresses another important question regarding the contribution of tilsotolimod when given in combination with ipilimumab.” The poster discussion is scheduled for Saturday, October 20, 2018 at 2:45 PM CEST (8:45 AM EST) in Room ICM-14b at the Messe Munchen Congress Center in Munich, Germany. In addition to the poster discussion, the company also presented a Trials in Progress (TiPS) poster on the trial design for the ongoing ILLUMINATE-301 Phase 3 clinical trial of the combination of tilsotolimod and ipilimumab for unresectable or metastatic melanoma following failure of PD-1 inhibitor treatment. This poster will be on display on Sunday, October 21, 2018 from 12:45 – 1:45 PM CEST (6:45 – 8:45 AM EST) in Hall A3 at the Messe Munchen Congress Center in Munich, Germany. Copies of these poster presentations are currently available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/. 4th Quarter Clinical Efficacy and Safety Update About Tilsotolimod (IMO-2125) About ILLUMINATE-204 For additional details about ILLUMINATE-204, please go to clinicaltrials.gov and search for study identifier NCT02644967. About ILLUMINATE-301 For additional details about ILLUMINATE-301, please go to clinicaltrials.gov and search for study identifier NCT03445533. About Metastatic Melanoma About Idera Pharmaceuticals Forward Looking Statements *Yervoy (ipilimumab) and Opdivo (nivolimumab) are registered trademarks of Bristol-Myers Squibb. **Keytruda (pembrolizimab) is a registered trademark of Merck & Co., Inc. 1 Rodig, S., et al., MHC proteins confer differential sensitivity to CTLA-4 and PD-1 blockade in untreated metastatic melanoma. Sci. Transl. Med. 10, eaar3342 (2018). IDERA PHARMACEUTICALS CONTACT: |
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