Merck collaborates on novel prostate cancer treatments

Merck has signed an agreement with Advaxis to develop cancer immunotherapies for prostate cancer.

The combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s investigational anti PD-1 antibody, pembrolizumab will be investigated. 

The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a phase I/II study of patients with previously treated metastatic, castration-resistant prostate cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumour immune response.

Several other big players are in the race to develop immunotherapy solutions, which work by enhancing the body’s own defences against cancer, including Bristol-Myers Squibb, Lilly, Roche and AstraZeneca.

Pembrolizumab is currently being evaluated across more than 30 types of cancer, as monotherapy and in combination. It is anticipated that, by the end of 2014, the pembrolizumab development programme will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide.

Daniel J O’Connor, President and CEO of Advaxis, said he believed the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors held significant promise for the treatment of prostate and other cancers.

The phase I part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab and phase II will assess the safety and efficacy of the combination. Advaxis will sponsor and fund the study, set to start in early 2015, and Merck will provide pembrolizumab.

Advaxis’ Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and MSDCs, that protect the tumour microenvironment from immunologic attack and contribute to tumour growth.

Prostate cancer is the second leading cause of cancer death in men, behind lung cancer. One man in six will get prostate cancer and one in 36 dies of this disease.


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