ASCO GU Conference Coverage

Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU

(Exelixis) Feb 13, 2021 - Exelixis, Inc. today announced positive phase 2 results for CABOMETYX® (cabozantinib) compared with sunitinib, the current preferred therapy according to U.S. cancer treatment guidelines,1 in patients with metastatic papillary renal cell carcinoma (PRCC), a form of kidney cancer. Data to be presented during the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium and simultaneously published in The Lancet.

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Exelixis Announces Final Phase 1 Results from Clinical Trial Sponsored by the National Cancer Institute at ASCO GU for Cabozantinib In Combination With Nivolumab With Or Without Ipilimumab In Patients With Refractory Metastatic Genitourinary Tumors

(Exelixis) Feb 12, 2021 - Exelixis, Inc. today announced positive final data for a phase 1 trial sponsored and conducted by the U.S. National Cancer Institute (NCI), including seven expansion cohorts, evaluating cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory metastatic genitourinary (GU) tumors. The data will be presented as part of the Rapid Abstract Session: Urothelial Carcinoma and Rare Tumors from 2:15 p.m. – 3:05 p.m. PT on Friday, February 12 at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021.

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Cabozantinib Best RX for Rare Kidney Cancer

(SWOG) Feb 13, 2021 - In a SWOG Cancer Research Network trial that put three targeted drugs to the test, the small molecule inhibitor cabozantinib was found most effective in treating patients with metastatic papillary kidney cancer – findings expected to change medical practice. These findings will be presented at ASCO’s virtual 2021 Genitourinary Cancers Symposium on Feb. 13, 2021 at 1 p.m. ET. The findings will be simultaneously published in The Lancet.

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Immunotherapy – Targeted Drug Combination Improves Survival In Advanced Kidney Cancer

(Dana-Farber) Feb 13, 2021 - Lenvatinib plus pembrolizumab yields better overall survival than single-agent sunitinib when given as first-line therapy in untreated patients with metastatic kidney cancer.

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Yale Cancer Center Study Shows Targeted Therapy Improves Survival for Advanced Bladder Cancer

(Yale Cancer Center) Feb 12, 2021 - In a new study led by researchers at Yale Cancer Center (YCC), the drug enfortumab vedotin (EV) significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma or bladder cancer, who had previously received platinum-based treatment and a PD-1–PD-L1 inhibitor. The results were published today in The New England Journal of Medicine (NEJM).

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Men With Early Stage Testicular Cancer Could Avoid Potentially Harmful Monitoring Scans

(ICR [UK]) Feb 12, 2021 - Men who have had treatment for early stage testicular cancer could benefit from fewer monitoring scans, freeing them from some of the harmful radiation that comes from computerized tomography (CT) imaging, according to results* from the TRISST** clinical trial presented at GU ASCO conference today (Friday).

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ImmunityBio Announces ASCO Genitourinary Cancer Symposium Presentation of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 71% Complete Response Rate

(Yahoo! Finance) Feb 16, 2021 - ImmunityBio, Inc. today announced the oral presentation of "Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients (Cohort A)" during a session at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).

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Astellas/Seagen Prepare Full US Filing Of Bladder Cancer Drug Padcev

(Pharmaphorum [UK]) Feb 15, 2021 - Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend.

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Asco-GU – Merck’s Peloton Gives Arrowhead a Slipstream

(Evaluate Vantage) Feb 15, 2021 - A little-noticed Merck & Co presentation at Asco-GU over the weekend should be of interest to followers of Arrowhead Pharmaceuticals. It concerns MK-6482, a HIF-2α inhibitor that now carries the INN belzutifan, in a relapsed renal cancer trial in combination with Exelixis’s Cabometyx.

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KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

(Merck) Feb 13, 2021 - Merck, known as MSD outside the United States and Canada, and Eisai today announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307) in an oral presentation session (Abstract #269) at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine. The trial evaluated the combinations of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

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Combination Belzutifan/Cabozantinib Shows Promise in Advanced Clear Cell Renal Cell Carcinoma

(ASCO Daily News) Feb 13, 2021 - The oral hypoxia-inducible factor 2ɑ (HIF-2ɑ) inhibitor belzutifan in combination with cabozantinib offered a promising response rate in patients with advanced clear cell renal cell carcinoma (RCC), according to interim phase II results presented during the 2021 Genitourinary Cancers Symposium (Abstract 272). “We know, over all, that over 90%, the vast majority, of patients with clear cell RCC do have a loss in the VHL gene,” said Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, who presented the new results. That loss leads to deficient VHL protein function and a pseudohypoxic state, which in turn leads to activation of HIF-2ɑ and upregulation of many downstream genes, including VEGF.

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Cabozantinib Offers Improved Progression-Free Survival Over Sunitinib in Advanced Papillary Renal Cell Carcinoma

(ASCO Daily News) Feb 13, 2021 - Treatment with cabozantinib resulted in better progression-free survival (PFS) than sunitinib in the phase II SWOG 1500 study of patients with metastatic papillary renal cell carcinoma (pRCC), while crizotinib and savolitinib showed no such improvement over sunitinib. “pRCC is a rare entity, constituting 15% of cases of RCC,” said Sumanta (Monty) Pal, MD, FASCO, of the City of Hope Comprehensive Cancer Center, who presented the results. “VEGF–directed therapies have constituted a standard of care in this disease, but the estimates of VEGF–directed therapy vary.”

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2021 GU Cancers Symposium: Lenvatinib Combos Improve PFS in Advanced RCC

(OBR) Feb 13, 2021 - Lenvatinib, combined with either pembrolizumab or everolimus, outperformed sunitinib monotherapy in progression-free survival (PFS) for patients with advanced renal cell carcinoma (RCC), according to findings presented at the American Society of Clinical Oncology’s 2021 Genitourinary Cancers Symposium. The combination of lenvatinib and pembrolizumab also bested sunitinib alone in terms of overall survival and objective response rate, supporting the regimen as a potential first-line treatment for advanced RCC, according to Robert J. Motzer, MD, who presented the findings of the phase 3 CLEAR study (Abstract 269).

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2021 GU Cancers Symposium: RETAIN BLADDER Trial Offers Promise for Sparing Cystectomy

(OBR) Feb 13, 2021 - Active surveillance after neoadjuvant chemotherapy may someday be an option for some patients with muscle invasive bladder cancer and certain predictive genomic factors, according to interim findings reported at the American Society of Clinical Oncology’s 2021 Genitourinary Cancers Symposium. In the interim analysis of the RETAIN BLADDER trial, which evaluated risk-enabled therapy following cisplatin-based neoadjuvant chemotherapy, 81% of patients in the active surveillance group were able to retain their bladder (Abstract 397). Follow up is underway for the primary endpoint of two-year metastasis-free survival.

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Front-Line Immunotherapy Improves Survival in Kidney Cancer Subtype, Versus Certain Targeted Therapies

(CureToday.com) Feb 11, 2021 - Patients with metastatic non–clear cell renal cell carcinoma who receive immune checkpoint inhibitor–based regimens as a first treatment option may have improved survival, versus those who receive select targeted therapies. Immune checkpoint inhibitor–based regimens administered as a first treatment option in patients with metastatic non–clear cell renal cell carcinoma (RCC) may be associated with improved overall survival, versus select targeted therapies.

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Seagen and Astellas Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

(Seagen) Feb 12, 2021 - Seagen Inc. and Astellas Pharma Inc. today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm EV-201 trial. In the trial, 52 percent of patients who received PADCEV® (enfortumab vedotin-ejfv) had an objective response (95 percent Confidence Interval [CI]: 40.8, 62.4) and the median duration of response was 10.9 months (95 percent CI: 5.8, NR).

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Seagen and Astellas Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

(Seagen) Feb 12, 2021 - Seagen Inc. and Astellas Pharma Inc. today announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received PADCEV in the trial lived a median of 3.9 months longer than those who received chemotherapy.

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Predicine to Present Data that Highlight Comprehensive Liquid Biopsy Solutions at 2021 ASCO-GU Cancers Symposium

(Predicine) Feb 11, 2021 - Data presentations to show clinical utility of Predicine’s urine- and blood-based liquid biopsy solutions for precision cancer care and clinical drug development.

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Molecular Signatures May Predict Response to Apalutamide in nmCRPC

(ASCO Daily News) Feb 11, 2021 - A molecular analysis from the SPARTAN trial shows that patients with non-metastatic castration-resistant prostate cancer (nmCRPC) whose tumors have features indicating increased immune activity, hormonal dependence, or lower proliferation at baseline may be more likely to derive long-term benefit from apalutamide plus androgen deprivation therapy (ADT).

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PROfound Shows Significant Antitumor Activity With Olaparib for mCRPC in Patients With DNA Repair Mutations

(ASCO Daily News) Feb 8, 2021 - An updated gene-by-gene analysis of DNA repair mutations in patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III PROfound study found that patients with BRCA alterations had the most significant antitumor activity on olaparib (Abstract 126), highlighting the potential overall survival (OS) benefit of genetic testing for all patients with high-risk mCRPC.

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