dm+d

Unassigned

New Medicines

BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ with or without Ta or T1 disease - with BCG

Information

New molecular entity
ImmunityBio
ImmunityBio

Development and Regulatory status

None
None
Pre-registration (Filed)
Jul 22FDA has assigned a target action date of 23/5/23 [5]
May 22ImmunityBio submits biologics license application (BLA) to the FDA for inbakiceptin combination with intravesical Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease. The BLA was submitted based on data from phase II/III QUILT-3032 trial [1,2]
Dec 19FDA grants breakthrough therapy designation to inbakicept for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). The breakthrough therapy designation applies for the development of inbakicept, in combination with Bacillus Calmette-Guerin (BCG) [2]
May 17FDA grants Fast Track designation to inbakicept for treatment of patients with non-muscle invasive bladder cancer (NMIBC). The Fast Track designation will apply to clinical development of inbakiceptin combination with BCG for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, as well as for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) in patients with NMIB [2]

Category

Recombinant interleukin-15 (IL-15) super agonist protein complex - a fusion complex of the IL-15N72D mutein with an IL-15Rα-IgG1 Fc. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding while avoiding T-reg stimulation [1,2]
Bladder cancer is the 11th most common cancer in the UK. It is the most frequently occurring tumour of the urinary system and accounts for around 3% of all new cases of cancer in the UK. There are around 10,300 new bladder cancer cases in the UK every year. The majority of cases occur in patients aged over 75 years. Men outnumber women by 3:1 but women tend to have a poorer prognosis [3]
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ with or without Ta or T1 disease - with BCG
Intravesical

Trial or other data

Jun 22ImmunityBio announce positive final clinical results of PII/II QUILT-3.032 (NCT03022825). Good safety and tolerability profile was demonstrated with no grade 4/5 adverse events. 71% complete remission rate at anytime was found with a median duration of response of 24.1 months. In responders, 91% avoided cystectomy and 96% achieved 24 month bladder cancer specific progression free survival. 99% bladder cancer specific overall survival at 2 years was observed [4]
Oct 21ImmunityBio announced that that Papillary disease (Cohort B) in the phase II/III QUILT-3.032 trial met its primary endpoints with disease-free survival of 57% of patients at 12 months [2]
Dec 20ImmunityBio announced that the phase II/III QUILT-3.032 trial met its primary end point in the first cohort for BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS) with 72% complete response rate [2]
Jun 17Altor Bioscience initiated PII/III QUILT-3.032 trial to assess the safety and efficacy of inbakiceptin combination with intravesical Bacillus Calmette-Guerin (BCG), administered by intravesical instillation, in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NCT03022825). The open-label, single-group trial will enroll approximately 183 patients in the US [2].