Overview
ImmunityBio (NASDAQ:IBRX) shares gained 7.5% on Thursday following regulatory approvals in the United Arab Emirates for ANKTIVA in two distinct cancer indications. The Emirates Drug Establishment issued marketing authorizations for ANKTIVA 0.4 mg used with BCG to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and for ANKTIVA 1.2 mg combined with immune checkpoint inhibitors to treat adult patients with metastatic non-small cell lung cancer (NSCLC).
Regulatory reach and significance
The UAE authorizations increase ANKTIVA's global regulatory reach to 34 countries and mark the fifth regulatory jurisdiction to approve the drug. Notably, the NMIBC approval granted by the Emirates Drug Establishment is described as the first approval worldwide to cover the full spectrum of BCG-unresponsive disease - this includes carcinoma in situ (CIS) with or without papillary tumors, as well as papillary disease alone without CIS.
Clinical data underpinning the NMIBC approval
The NMIBC authorization is supported by results from the QUILT-3.032 trial. In the trial's CIS cohort of 100 patients, the combination of ANKTIVA plus BCG produced a complete response rate of 71%, with the duration of complete response extending beyond 54 months. In a separate papillary-only cohort of 80 patients, the 12-month disease-free survival rate was 58.2%, and the cystectomy-free rate at 36 months was 83%.
Clinical basis for the NSCLC approval
The NSCLC authorization applies to adult patients with metastatic disease that progressed on or after standard of care, including checkpoint inhibitor failure. That approval rests on data from the QUILT-3.055 trial, which reported a median overall survival of 14.6 months in 79 patients with checkpoint-refractory advanced NSCLC.
Context on disease management
ImmunityBio noted that BCG-unresponsive NMIBC carries a high risk of progression. Historically, radical cystectomy has been the standard treatment option for patients who fail BCG therapy.
Market reaction and closing note
The UAE approvals and the clinical results cited by the company were followed by a positive share-price response on Thursday. The authorizations expand ANKTIVA's regulatory footprint and formalize indications in both bladder and lung cancer as described above.