- Results from the Phase 2 Expansion of ILLUMINATE-204 anticipated to be reported in the 4th Quarter of 2019 –
52 patients have been dosed in the trial which included two separate patient groups. The company completed the targeted enrollment of 40 patients in the primary enrollment population, constituting patients who are naïve to prior ipilimumab treatment in the metastatic setting. This patient population mirrors the enrollment for the ILLUMINATE-301 phase 3 pivotal trial. The secondary exploratory enrollment population targeted up to 20 patients who had prior ipilimumab treatment in the metastatic setting.
The ILLUMINATE-204 trial is a multi-center trial being conducted at 10 sites throughout
The company is currently enrolling ILLUMINATE-301, a global, multi-center, randomized Phase 3 trial that compares effectiveness and safety between two treatment groups: tilsotolimod combined with ipilimumab versus ipilimumab given alone. This trial is being conducted at up to 100 centers with a target enrollment of 308 patients. Enrollment remains on track and is expected to be completed in the 4th quarter of 2019.
The company also recently received notice from the
“We made tremendous progress with the clinical development of tilsotolimod in the second half of 2018, and enrollment in the phase 3 study in patients with melanoma progressing on PD-1 therapy is tracking to complete by the end of 2019.” stated
As a reminder, the company provided an interim data update from the ILLUMINATE-204 trial in December 2018.
Summary of ILLUMINATE-204 Key Findings from the
- 37 patients dosed with 8 mg of tilsotolimod in combination with ipilimumab were evaluated for the
- All 37 patients were evaluable for safety;
- The combination regimen continues to be generally well tolerated. 9/37 subjects (24.3%) had immune-related toxicities indicating that tilsotolimod + ipilimumab does not appear to add immune-related toxicity versus ipilimumab alone;
- Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours;
- 34 patients were evaluable for efficacy;
- Responses, including 3 Complete Responses (CR), were observed in 11 of the 34 evaluable patients (32.4%);
- Duration of response ranges from > 1 month to > 30 months, with 36% of responses ongoing at the time of the report;
- Per RECIST v1.1, the Overall Response Rate (ORR) is 29.4%; one patient with an unconfirmed Partial Response (uPR) at the end of treatment assessment progressed due to a new lesion at the 3-month follow-up disease assessment;
- Overall, 26 patients out of 34 evaluable for efficacy (76.5%) experienced disease control (CR, PR, or Stable Disease [SD]);
- Analysis of spider plots show tumor shrinkage in both injected and uninjected lesions, indicating an abscopal effect;
- Responding subjects include one patient with mucosal melanoma and one patient with acral melanoma, two forms of melanoma that are particularly difficult to treat; and
- Importantly, 2 of 5 patients with prior ipilimumab experience achieved responses, further demonstrating a signal that tilsotolimod has the potential to help overcome prior ipilimumab resistance.
- A RECIST v1.1 PR of > 2.5 years is ongoing in 1 patient treated with tilsotolimod 4 mg in combination with ipilimumab; and
- A RECIST v1.1 CR of > 1 year is ongoing in 1 patient treated with tilsotolimod 16 mg in combination with pembrolizumab.
About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the
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.
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. 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.
The ILLUMINATE-206 study (2125-206) is a Phase 2 multi-center, multi-cohort study of intratumoral tilsotolimod in combination with nivolumab and ipilimumab in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are either immunotherapy naïve and immunotherapy refractory and immunotherapy naïve patients with Microsatellite Stable Colorectal Cancer (MSS-CRC). The trial is expected to open for enrollment in the second quarter of 2019.
About Metastatic Melanoma
Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths.
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 (nivolumab) are registered trademarks of
**Keytruda (pembrolizimab) is a registered trademark of
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Source: Idera Pharmaceuticals, Inc.