Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Efficacy was evaluated in QUILT-3.032 (ClinicalTrials.gov Identifier: NCT0302285), a single-arm, multicenter trial of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection. Patients received nogapendekin alfa inbakicept-pmln induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months.
Tumor status was assessed with cystoscopy and urine cytology every three months for up to two years, and biopsy (random or cystoscopy-directed) was required within the first six months after treatment initiation. Subsequent assessment was performed per local community standards.
The major efficacy outcome measures were complete response (CR) at any time and duration of response (DOR). CR was defined by a negative cystoscopy (with a transurethral resection of bladder tumor/biopsies as applicable) and urine cytology.
The CR rate was 62% (95% CI, 51%-73%). Fifty-eight percent of patients with CR had a DOR of at least 12 months and 40% had a DOR of at least 24 months.
The most common adverse reactions (≥15%), including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.
The full prescribing information for nogapendekin alfa inbakicept-pmln is posted here.
Based on a press release from the FDA.
