Biotech Values

[DewDiligence]

ADXS reports preliminary AXAL-Durvalumab* combination data in cervical or H&N cancer:

http://finance.yahoo.com/news/advaxis-present-phase-1-combination-123000192.html

This Phase 1 (Part A; 3+3) dose-escalation study was designed to assess the overall safety and select the recommended phase 2 dose (RP2D) of AXAL in combination with durvalumab in patients with recurrent/metastatic cervical or HPV+ HNSCC cancer. Patients received AXAL (1×10^9 colony-forming units [CFU]) every four weeks and durvalumab (3 mg/kg or 10 mg/kg) every two weeks.

Preliminary results from Part A dose escalation showed that there were no dose limiting toxicities observed, and the safety profile was consistent with previous findings for both AXAL and durvalumab. The recommended phase 2 dose was established as 1×10^9 CFU for AXAL and 10 mg/kg for durvalumab.

One patient with cervical cancer achieved a complete response, which remains ongoing after 12 months of follow-up, and one patient, also with cervical cancer, achieved a partial response with subsequent disease progression. In addition, two patients with HNSCC achieved stable disease. Treatment related adverse events (TRAE) were reported in 91 percent of patients; the majority were either grade 1 or grade 2 events such as chills, fever, nausea and hypotension. Grade 3 TRAEs occurred in three patients, and one patient experienced a grade 4 event.

Note: AXAL monotherapy is being tested against placebo in a phase-3 trial in adjuvant cervical cancer (https://www.clinicaltrials.gov/ct2/show/NCT02853604 ).

*Durvalumab is AZN’s PD-L1 (checkpoint) inhibitor.