ASCO GU 2019: PIVOT-02 Study of NKTR-214 with Nivolumab in Metastatic Urothelial Carcinoma

San Francisco, CA ( Immune checkpoint inhibitors are approved both in the first line and second line for patients with metastatic urothelial carcinoma. In the first line, KEYNOTE 052 showed that pembrolizumab has significant anti-tumor activity for cisplatin ineligible patients with UC1, for a 38% objective response rate for patients with a combined positive score of 10% or more (PD-L1 positive). Further analysis last year found that the benefit to checkpoint inhibition in the first line was restricted to patients with a high PD-L1 expression, as defined by CPS≥10 or PD-L1 IC ≥5%. In the second line, KEYNOTE 045 improved median overall survival compared with chemo (10.3 v 7.4 months; HR, 0.70; P < 0.001)2.

ASCO GU 2019: Gemcitabine-Carboplatin versus Gemcitabine-Oxaliplatin In Cisplatin Un-Fit Advanced Urothelial Carcinoma: Randomized Phase II Study-COACH Study

San Francisco, CA ( The first line chemotherapy in advanced metastatic urothelial carcinoma is cisplatin-based. The two most accepted options are gemcitabine + cisplatin (GC) or Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC).  In patients who are unfit to receive cisplatin-based chemotherapy (approximately 30-50% of patients), the available options include gemcitabine and carboplatin, or immune checkpoint inhibitors such as pembrolizumab or atezolizumab for patients with high PD-L1 expression. Gemcitabine and carboplatin have been shown to harbor significant adverse events such as neutropenia (52.5%), thrombocytopenia (48.3%), febrile neutropenia (4.2%), grade 3 or 4 infections (11.8%), and severe acute toxicity (9.3%).1,2

ASCO GU 2019: CheckMate 9UT - Nivolumab or Nivo Plus BMS-986205 with or without Intravesical Bacillus Calmette-Guerin in BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

San Francisco, CA ( Immune checkpoint inhibitors, including the anti-PD1 monoclonal antibody nivolumab, have demonstrated favorable tolerability and efficacy profiles, ushering a new treatment paradigm for advanced bladder cancer. Nivolumab has a meaningful clinical benefit in patients with advanced bladder cancer, whose disease progressed or recurred following treatment with platinum-based chemotherapy (objective response rate of 20%), and a manageable safety profile. However, an unmet need exits for new effective treatment options in an earlier stage of the disease, including patients with BCG-unresponsive, high risk- non-muscle invasive bladder cancer (NMIBC). 

ASCO GU 2019: POTOMAC Study - Durvalumab and BCG versus BCG Alone in High-risk, BCG-Naïve Non Muscle-Invasive Bladder Cancer

San Francisco, CA ( Urothelial carcinoma is the most common type of cancer of the bladder, urethra, and urachus, accounting for 90% of primary malignancies of the urinary tract. Standard treatment for patients with high-risk tumors is transurethral resection (TURBT) followed by intravesical BCG. Despite the efficacy of BCG, recurrence rates are as high as 50% in the first three years of follow-up and can be even higher for aggressive histologic subtypes.  Antitumor immune response has been shown with the targeting of the programmed cell death ligand-1/programmed cell death-1 (PD-L1/PD-1). The response rates have shown to be doubled with immunotherapy targeting PD-1 and PD-L1 compared to standard chemotherapy.

ASCO GU 2019: Pembrolizumab in Treating Patients With Locally Advanced Bladder Cancer

San Francisco, CA ( Patients with high-risk muscle-invasive bladder cancer (MIBC) have a poor prognosis. Radical cystectomy remains the standard treatment for these patients. However, even though the surgical technique has been significantly refined and improved, mortality from metastatic recurrence after surgery remains considerably high. Many MIBC patients are ineligible for cisplatin-based chemotherapy (almost 50%) or have persistent MIBC despite neoadjuvant chemotherapy (NAC). Additional treatments are therefore needed for these patients. 

ASCO GU 2019: Ramucirumab Exposure-Response Relationship in RANGE: Trial in Advanced Platinum-Refractory Urothelial Carcinoma

San Francisco, CA (  Patients with advanced or metastatic, platinum-refractory urothelial carcinoma (UC) have limited treatment options. RANGE is an international, randomized, double-blind, phase 3 trial that assessed the safety and efficacy of treatment with docetaxel plus either ramucirumab (RAM), a human IgG1 VEGFR-2 antagonist, or placebo. It was demonstrated that docetaxel plus RAM was associated with superior progression free survival (PFS) compared to docetaxel chemotherapy alone in platinum-refractory advanced UC, validating the VEGF-2 pathway as a therapeutic target in the treatment of such patients. The present study reports the exposure-response and overall survival relationships for RAM in the RANGE study. 

ASCO GU 2019: Pembrolizumab in Muscle-Invasive and Locally Advanced Urothelial Carcinoma - AMBASSADOR versus Observation

San Francisco, CA ( Patients with high-risk muscle-invasive bladder cancer (MIBC) have a poor prognosis. Adjuvant cisplatin-based neoadjuvant chemotherapy has been shown to improve survival, but a large number of these patients are resistant to chemotherapy and develop recurrent disease. Due to renal insufficiency, many patients are also not cisplatin-eligible.  Therefore, there is a need to develop additional treatment options.
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