Idera Pharmaceuticals Presents Clinical Data from the ILLUMINATE-204 Trial of the Combination of tilsotolimod and ipilimumab for Anti-PD-1 Refractory Metastatic Melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
- Data from Ongoing Phase 2 Study to be Presented at
- Of 21 patients evaluable for efficacy, 38% Overall Response Rate (ORR) observed including 2 Complete Responses (CR); Disease Control Rate observed to be 71% (15 of 21 patients achieving Stable Disease (SD) or better) -
- The combination regimen is generally well tolerated and no synergistic toxicity was observed -
“We have clinical evidence that tilsotolimod activates both the innate and adaptive immune responses, and when used in combination with a checkpoint inhibitor like ipilimumab, triggers immune responses in previously resistant tumors,” stated
The data available for presentation includes 26 patients whose disease had progressed on anti PD-1 therapy. 21 were evaluable for efficacy [reached first disease assessment as of
ILLUMINATE-204 Key Findings:
- 21 patients treated with the 8 mg dose of tilsotolimod in combination with ipilimumab have had disease evaluations;
- Confirmed RECIST v1.1 responses (including 2 Complete Response [CR]) were observed in 8 of these 21 subjects (38.1%);
- Six of 8 responses are ongoing (1 CR ongoing for nearly 2 years); median duration of response for these 8 has not yet been reached;
- Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);
- The combination regimen is generally well tolerated. 6/26 subjects (23%) had immune-related toxicities indicating that IMO-2125 + ipilimumab does not appear to add toxicity versus ipilimumab alone.
- Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours; and,
- 15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included.
Additionally:
- A RECIST v1.1 PR of > 2 year duration is ongoing in a patient treated with tilsotolimod 4 mg in combination with ipilimumab; and
- A RECIST v1.1 CR is ongoing in a patient treated with tilsotolimod 16 mg in combination with pembrolizumab.
“Patients with melanoma and metastatic disease progressing on anti-PD-1 therapy have limited treatment options and need rapid intervention,” stated
A copy of the poster presentation is currently available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/.
Two additional abstracts were accepted for publication by the review committee:
Title: | Preliminary safety of deep/visceral (D/V) image guided (IG) intratumoral injection (ITI) of IMO-2125. |
Abstract Number | |
For Publication: | e15150 |
Author: | Hani Babiker, MD, University of Arizona Cancer Center |
Title: | Right tumor, right time: Systematic methodology for fiducial marker placement to achieve reliable and reproducible image guided (IG) delivery of intratumoral immunotherapy into deep/visceral (D/V) lesions and target-lesion imaging follow-up |
Abstract Number | |
For Publication: | e24137 |
Author: | Gregory John Woodhead, MD, PhD, University of Arizona Cancer Center |
Investor Event and Webcast
The company plans to hold an investor/analyst event at the ASCO Annual Meeting on
The webcast can be accessed live or in archived form in the “Investors” section of the company’s website at www.iderapharma.com. The company plans to post a slide presentation on
About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the
About ILLUMINATE-204
The ILLUMINATE-204 study (2125-204) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda®** (pembrolizumab) or Opdivo®* (nivolumab) has failed. Melanoma is the most dangerous type of skin cancer. When it is metastatic, it means that the melanoma has spread to different parts of the body. ILLUMINATE-204 is a multi-center, two-arm Phase 1/2 study that tests the safety and effectiveness of tilsotolimod in combination with either ipilimumab (Yervoy®) or pembrolizumab (Keytruda®) for the treatment of patients with anti-PD-1 refractory metastatic melanoma.
For additional details about ILLUMINATE-204, please go to clinicaltrials.gov and search for study identifier NCT02644967.
About ILLUMINATE-301
The ILLUMINATE-301 study (2125-MEL-301) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda® (pembrolizumab) or Opdivo® (nivolumab) has failed. ILLUMINATE-301 is a global, multi-center, randomized Phase 3 study that compares the effectiveness and safety between two treatment groups: IMO-2125 combined with ipilimumab (Yervoy®) versus ipilimumab given alone.
For additional details about ILLUMINATE-301, please go to clinicaltrials.gov and search for study identifier NCT03445533.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system, liver or other visceral organs (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths.
About
Harnessing the approach of the earliest researchers in immunotherapy and the Company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
*Yervoy (ipilimumab) and Opdivo (nivolimumab) are registered trademarks of
**Keytruda (pembrolizimab) is a registered trademark of
IDERA PHARMACEUTICALS CONTACT:
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Source: Idera Pharmaceuticals, Inc.