SYDNEY—Immutep Ltd., a biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, has secured a deal with Merck & Co. (known as MSD outside of the United States and Canada) via a subsidiary. The deal will assess eftilagimod alpha (efti, or IMP321), Immutep's lead immunotherapy product candidate, and Keytruda, Merck's anti-PD-1 therapy, in a clinical trial of the combination regimen in a number of different solid tumors.
IMP321 is a soluble LAG-3lg fusion protein based on the LAG-3 immune control mechanism, which plays a key role in regulating the body's T cell immune response. The product candidate has completed early Phase 2 trials alone and together with other therapeutics as an antigen presenting cell activator, boosting T cell responses to cancer chemo-immunotherapy.
“We are extremely pleased to be collaborating with MSD, one of the world’s leading immuno-oncology companies,” Marc Voigt, CEO of Immutep, said in a press release. “This clinical trial will evaluate a novel combination of two complementary immuno-oncology treatments in three cancer indications simultaneously, which could lead to more rapid drug development subject to successful outcomes. The data generated thus far from our ongoing TACTI-mel clinical trial has supported our hypothesis that there is a compelling therapeutic synergy in administering efti in combination with another immuno-oncology treatment. This new Phase 2 clinical trial significantly builds on the momentum we are delivering in the evaluation of efti in cancer, with two Phase 1 clinical trials and now two Phase 2 clinical trials in our program for 2018.”
The newly announced Phase 2 clinical trial, TACTI-002 (Two ACTive Immunotherapies), will evaluate the safety and efficacy of IMP321 and Keytruda in patients with non-small cell lung cancer, head and neck cancer or ovarian cancer. This trial will be a Phase 2, Simon two-stage, non-comparative, open-label, single-arm, multi-center clinical study. The trial will enroll up to 120 patients across the three indications in medical centers in Europe and the United States, with an expected start date in the second half of 2018.
This is the second agreement involving Keytruda for Merck in as many weeks. On March 7, the company announced a strategic collaboration with Eisai Co. Ltd. to co-develop and co-commercialize Lenvima, an orally available tyrosine kinase inhibitor discovered by Eisai.
Per the agreement, Eisai and Merck will develop the compound jointly, both as a monotherapy and in combination with Keytruda. Eisai will book Lenvima product sales globally, as a monotherapy and in combination, and the two companies will split gross profits equally. Merck and Eisai will jointly initiate new clinical studies to evaluate the combination regimen in 11 potential indications involving six types of cancer—non-small cell lung cancer, endometrial cancer, hepatocellular cancer, head and neck cancer, bladder cancer and melanoma—in addition to a basket trial of multiple cancer types.
One Phase 3 study is already underway under Eisai, seeking to compare Lenvima and Keytruda or Lenvima and everolimus versus chemotherapy alone for the treatment of renal cell carcinoma. The combination of Keytruda and Lenvima received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in January for the treatment of advanced and/or metastatic renal cell carcinoma.
“Together with Eisai, we aim to maximize the value of Lenvima for its current indications while jointly pursuing additional approvals in combination with Keytruda across a wide range of cancers,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories. “There is strong scientific evidence supporting synergistic effects of Keytruda when used in combination with Lenvima, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the Keytruda/Lenvima combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”