Advaxis presents new long-term survival data at ASCO Annual Meeting

PRINCETON, N.J.—Advaxis, Inc, a biotechnology company developing cancer immunotherapies, presented final results from the Phase 2 clinical study of its lead immunotherapy product candidate, ADXS-HPV (ADXS11-001), in women with recurrent cervical cancer at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. These data showed that ADXS-HPV was well-tolerated and that 22 percent (24/109) of the patients were long-term survivors (LTS) 18 months. 18 percent (16/91) of patients were alive for more than 24 months.

The poster presentation highlighted data on the LTS with recurrent cervical cancer who were treated with ADXS-HPV monotherapy or ADXS-HPV with cisplatin chemotherapy. Of the 109 patients treated in the study, LTS included not only patients with tumor shrinkage but also included patients who experienced increased tumor burden as their best tumor response overall. Seventeen percent (19/109) of the patients in the trial had recurrence of disease after at least two prior treatments for their cervical cancer; these patients comprised 8 percent (2/24) of LTS. Among the LTS, 25 percent (3/11) of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 2, a patient population that is often times excluded from clinical trials because of their poor survival.

"Long-term survivors in recurrent cervical cancer are rare," commented, Dr. Robert Petit, executive vice president and chief scientific officer of Advaxis. "To our knowledge, ADXS-HPV is the first immunotherapy to be associated with objective tumor responses (including complete responses and partial responses) and also with long-term survival either as a monotherapy or in combination with cisplatin chemotherapy. The LTS included patients with poor performance status, those who had progressed after combination chemotherapy in the recurrent setting, and several patients whose best tumor response was progressive disease during the trial. To achieve these results from a single cycle of an immunotherapy in patients with poor prognoses is remarkable and supports further development. We intend to evaluate whether higher doses and multiple treatment cycles of ADXS-HPV can further improve clinical outcomes in this resistant disease with improved quality of life."

The poster presentation also provided the final audited data which showed that, 22 percent (24/109) of patients survived 18 months, and 32 percent (35/109) of patients survived 12 months, despite the poor prognosis of this patient population. The tumor response rate was 11% (including complete responses and partial responses) with a median duration of response of 9.5 months. A disease control rate (greater than or equal to three months) was observed in 38 percent (42/109) of patients. The addition of cisplatin chemotherapy did not improve either survival or tumor response over monotherapy with ADXS-HPV. ADXS-HPV was well tolerated as 62 percent (68/109) of patients reported no adverse events and 38 percent (41/109) of patients reported mild transient adverse events (Grade 1 or 2) that occurred on the day of infusion. One patient experienced a serious adverse event which was reported as a Grade 3 fever.

Daniel J. O'Connor, chief executive officer of Advaxis stated, "The final results from this study provide the justification for Advaxis to move forward with a registration program in recurrent cervical cancer. This clinical development program has been further strengthened by the recent receipt of Orphan Drug Designation from the FDA and the continuing collaborative efforts with our licensing partners in those territories that account for the highest global burden of cervical cancer in the world."

Cervical cancer is the first cancer recognized by the World Health Organization (WHO) to be 100 percent attributable to an infection with high-risk HPV genotypes and is the third most common cancer among women. It is the leading cause of death overall among women in developing nations, where more than 80 percent of cervical cancer cases occur. While early detection and treatment provide a good prognosis, women diagnosed with invasive cervical cancer have about a 30 percent risk of recurrence, with fewer than 15 percent of patients surviving one year.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform intended to redirect the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only known cancer immunotherapy shown in preclinical studies to neutralize regulatory T cells (Tregs) and myeloid-derived suppressor cells (MSDCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug status for each of these three indications.

The company plans to initiate a registrational clinical program for cervical cancer in 2014 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis' second immunotherapy candidate is ADXS-PSA which is being developed to address prostate cancer. Advaxis is planning to file an IND with the FDA and initiate a Phase 1 clinical study with ADXS-PSA in 2014. Advaxis is also developing ADXS-cHER2, to target the HER2 receptor, which is over expressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal health, and has seen promising results in canine osteosarcoma, a model for human bone cancer. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other immunotherapy constructs to a major animal-health company. Advaxis is planning to file an IND for ADXS-cHER2 in HER2 over expressing cancers.

Advaxis Chief Operating Officer Gregory Mayes invites readers who may have an antigen of interest to contact Advaxis.