|The following article features coverage from the 2020 Genitourinary Cancers Symposium meeting. Click here to read more of Renal and Urology News’ conference coverage.|
SAN FRANCISCO—Combination neoadjuvant therapy with the checkpoint inhibitor nivolumab and gemcitabine-cisplatin for muscle-invasive bladder cancer (MIBC) showed encouraging results in a phase 2 trial, with most patients experiencing significant downstaging at radical cystectomy (RC), an investigator reported at the 2020 Genitourinary Cancers Symposium.
Of 41 patients with MIBC in the study, 27 (66%) experienced a pathologic response, the study’s primary endpoint, and 20 (49%) had a pathologic complete response, Shilpa Gupta, MD, of the Cleveland Clinic told attendees during an oral session. No patient experienced a delay in time to RC or unexpected surgical complications.
Trial enrollment criteria include the presence of cT2-T4a tumors, involvement of no more than 1 lymph node, and no metastases. Most patients (90%) had stage cT2N0 disease. Dr Gupta and her collaborators defined pathologic response as downstaging to less than pT2N0 disease and pathologic complete response as downstaging to pT0 or pTis disease. Of the 41 patients, 2 refused surgery but were included in the intent-to-treat population.
The combination therapy was safe with manageable toxicities and no treatment-related deaths, according to Dr Gupta. Most adverse events (AEs) were due to gemcitabine-cisplatin therapy. The overall rate was grade 3 or 4 AEs was 20%, most commonly neutropenia, thrombocytopenia, and renal insufficiency. Three patients had immune-related AEs. No patient experienced unexpected surgical complications from treatment. PD-L1 status did not correlated with outcome. The investigators are following patients for progression and survival.
Disclosure: Research funding provided by Bristol Myers-Squibb.
Read more of our coverage of the 2020 Genitourinary Cancers Symposium by visiting the conference page.
Gupta S, Sonpavde G, Weight CJ, et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Presented at the 2020 Genitourinary Cancers Symposium held February 13 to 15 in San Francisco. Abstract 439.