Bladder Cancer

In a 14-0 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) denied the approval of apaziquone (EOquin; Qapzola) for intravesical instillation immediately following transurethral resection in patients with non-muscle invasive bladder cancer.

A type II variation application for the use of nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) who have progressed following platinum-based chemotherapy is now under formal review.

Though the current standard of care when treating muscle-invasive bladder cancer calls for neoadjuvant chemotherapy followed by radical cystectomy, the procedure is associated with a fair amount of morbidity and is not suggested lightly, according to Stanley Yap, MD.

Cell cycle progression (CCP) and homologous recombination deficiency (HRD) may be linked to bladder cancer recurrences and pathologic complete responses, according to Hristos Kaimakliotis, MD.

Alexander I. Sankin, MD, assistant professor of Urology at Montefiore Medical Center at the Albert Einstein College of Medicine, discusses the differences between the recently defined checkpoint HHLA2 and PD-L1 expression in urothelial tumors, as well as next steps in this space.

The field of metastatic bladder cancer—an area that had long been stagnant—has quickly evolved with the recent FDA approval of atezolizumab (Tecentriq) coupled with the breakthrough therapy designation of nivolumab (Opdivo).

Across the fields of renal cell carcinoma, bladder cancer, and prostate cancer, immunotherapy agents are moving through the pipeline and impacting patient outcomes—some quicker than others.

The treatment paradigm of metastatic urothelial carcinoma was shaken up in May 2016 when the FDA approved the PD-L1 inhibitor atezolizumab for the treatment of patients with locally advanced or metastatic disease.

Atezolizumab proves to be non-toxic and shows major survival advantage in patients with metastatic urothelial bladder cancer.

Stanley Yap, MD, assistant professor, urologic oncology, UC Davis Comprehensive Cancer Center, discusses needed improvements and next steps in neoadjuvant chemotherapy for muscle-invasive bladder cancer.

The FDA has granted nivolumab a breakthrough therapy designation for the treatment of patients with resectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.

The PD-L1 inhibitor durvalumab demonstrated an objective response rate of 46% for patients with high PD-L1-expressing advanced urothelial bladder cancer.

The recent FDA approval of atezolizumab was a significant milestone for the second-line treatment of locally advanced bladder cancer, with even greater potential still on the horizon for the PD-L1 agent.

Jonathan E. Rosenberg, MD, medical oncologist, Memorial Sloan Kettering Cancer, discusses what is on the horizon for the treatment landscape of bladder cancer.

Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).

Neratinib, an experimental TKI being developed for breast cancer, achieved a 36% clinical benefit rate in a phase II trial, according to a poster presented June 5, 2016 at the ASCO Annual Meeting in Chicago.

Arjun V. Balar, MD, assistant professor, Department of Medicine, co-leader of the Genitourinary Cancers Program, discusses updated results of cohort 1 of the IMvigor 210 study.

The immunotherapy agent atezolizumab (Tecentriq) reduced the size of tumors by 24% in patients with metastatic urothelial carcinoma (mUC), according to phase II clinical trial results presented at the 2016 ASCO Annual Meeting.

Sue Naeyaert, senior director of Biosimilars Policy, EMD Serono, discusses the long-term impact that biosimilars could potentially have on the field of oncology.

The FDA has granted an accelerated approval to the PD-L1 inhibitor atezolizumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma following a platinum-based chemotherapy.

Daniel P. Petrylak, MD, professor of medicine at Yale University Cancer Center discusses the IMvigor Study, which looked at anti PD-1 agent atezolizumab in advanced urothelial carcinoma.

An upcoming FDA decision for the PD-L1 inhibitor atezolizumab as a treatment for patients with bladder cancer could set the stage for an onslaught of new and highly effective immuno-oncology agents, according to Daniel Petrylak, MD.

A recent study has shown that extracting cell-free DNA from urine is a highly effective technique for analyzing the genetic profile of urothelial bladder cancers.

The PD-L1 inhibitor atezolizumab has gained priority review status from the FDA as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC).

Immune checkpoint inhibitors have shown promising findings for patients with advanced bladder cancer, with data from phase II studies submitted to the FDA for consideration. The next question facing oncologists is how to optimally utilize these agents, according to James L. Gulley, MD, PhD.

Hoffman-Censits says atezolizumab has recently undergone a phase II clinical trial for patients with bladder cancer who failed platinum-based chemotherapy.

Siefker-Radtke says her preferred mathod of neoadjuvant chemotherapy is doxorubicin plus ifosfamide with an alternating regimen of etoposide cisplatin.

The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.

Gulley says there is no standard procedure for the third line setting in bladder cancer, and that most oncologists would either turn to single-agent chemotherapy or to clinical trials.

Adjuvant chemotherapy was associated with improved overall survival (OS) compared with observation postcystectomy in patients with pathologic T3/4 and/or pathologic node-positive bladder cancer, according to a retrospective analysis published in the Journal of Clinical Oncology.