New Study to Assess ADXS-DUAL, Opdivo Immunotherapy Combo in Metastatic Cervical Cancer

Advaxis and Bristol-Myers Squibb have entered a clinical collaboration to evaluate the second generation of axalimogene filolisbac, called ADXS-DUAL, in combination with Opdivo (nivolumab) in women with metastatic cervical cancer.

In particular, the study will assess the combination in patients with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who failed at least one prior line of chemotherapy. The trial, expected to start by the end of 2017, will be sponsored by Advaxis.

“Combining immunotherapy agents is at the core of Bristol-Myers Squibb’s strategy, as it brings the opportunity to improve anti-tumor efficacy,” Fouad Namouni, MD, head of the oncology development at BMS, said in a press release.

“We are excited to work with Advaxis to explore the potential of Opdivo and ADXS-DUAL to provide a potential new option for metastatic cervical cancer patients where there is a high unmet need,” he added.

Axalimogene filolisbac is an immunotherapy vaccine that targets cancers associated with the human papillomavirus, or HPV. It uses bioengineered live Listeria monocytogenes bacteria that secrete a fusion of the HPV-16 and a Listeria protein.

When immune cells clear the bacteria from a patient’s body, they begin recognizing HPV-16 as foreign and malignant, generating T-cells that go after HPV-positive cancer cells.

Axalimogene filolisbac is currently being studied in the global AIM2CERV Phase 3 trial (NCT02853604), and results from the GOG-0265 Phase 2 trial (NCT01266460) have shown that the vaccine leads to a 50 percent increase in patients’ 12-month overall survival rate.

ADXS-DUAL is the next generation of axalimogene filolisbac, secreting fusion proteins from both major families of HPV, HPV-16 and HPV-18. This will greatly increase the number of cervical cancer patients in which the vaccine is effective.

“The additional HPV antigens have the potential to provide coverage against numerous HPV types in cervical cancer and other HPV-associated cancers,” said Daniel J. O’Connor, president and CEO of Advaxis. “By studying the combination of Opdivo and ADXS-DUAL, we hope to bring a new option to metastatic cervical cancer patients with persistent, recurrent or metastatic disease. We are looking forward to working with Bristol-Myers Squibb to explore the potential of this combination.”