Idera Pharmaceuticals has completed patient enrollment in its ILLUMINATE-301 registrational trail evaluating tilsotolimod in combination with ipilimumab in patients with anti-PD-1 refractory advanced melanoma.

The randomised, Phase III trial is designed to compare the effectiveness of intratumoral tilsotolimod in combination with ipilimumab and with ipilimumab alone.

It has a primary endpoint family of overall response rate (ORR) per RECIST v1.1 and overall survival (OS). Secondary endpoints include durable response rate, time to response, progression-free survival, patient-reported outcomes, and safety.

The ILLUMINATE-301 trial has enrolled 481 patients across 80 sites in 11 countries.

The ORR and other preliminary data from ILLUMINATE-301 are expected to be announced in the first quarter of next year.

Tilsotolimod is an investigational receptor 9 agonist. Its intratumoral injection is said to assist innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

Tilsotolimod received both fast-track designation and orphan drug designation from the US Food and Drug Administration (FDA). The drug is currently being analysed in multiple tumour types in combination with multiple checkpoint inhibitors.

Idera Pharmaceuticals CEO Vincent Milano: “We are making outstanding progress in moving toward our goal of delivering tilsotolimod to the market in our lead indication for anti-PD-1 refractory advanced melanoma patients.

“We achieved this critical milestone earlier than anticipated, which we believe is truly a testament to the high unmet need facing these patients.”

American Cancer Society has estimated that almost 100,000 people in the US will be diagnosed with invasive melanoma this year.