Page 9

19544GA

Kidney Cancer Journal 129 MEDICAL INTELLIGENCE Highlighting Key Developments in Clinical and Strategic Thinking From Web-Based Sources Squibb, Calithera Biosciences Announce Clinical Collaboration to Evaluate Ninvolumab in Combination with CB-839 in Clear Cell RCC NEW YORK and SOUTH SAN FRANCISCO—A clinical trial collaboration will evaluate nivolumab (Opdivo®) in combination with Calithera’s CB-839 in patients with clear cell renal cell carcinoma (ccRCC). CB-839 is an orally administered glutaminase inhibitor currently in Phase 1/2 clinical studies. Preclinical data suggest that CB-839, designed to target a pathway to starve tumor cells of the key nutrient glutamine, may enhance the effects of checkpoint inhibitors and may also reverse tumor resistance to checkpoint inhibitors by altering the immune-suppressive microenvironment and promoting an anti-tumor immune response. Nivolumab is designed to overcome immune suppression. The companies will explore the potential of combining these two agents with the goal of achieving improved and sustained efficacy in ccRCC patients with cancer that is stable or growing on a PD-1 inhibitor therapy. “The combination with Opdivo follows our strategy to combine CB-839 with therapies to improve outcomes for RCC patients,” said Susan Molineaux, CEO of Calithera Biosciences. “We believe that by blocking glutamine consumption in tumors, and redirecting this key nutrient for cell growth and proliferation to T-cells, CB-839 could enhance the effects of Opdivo. With support from Bristol-Myers Squibb, Calithera is excited to advance this combination into the Phase 2 portion of CX-839-004, our ongoing study in ccRCC patients.” Opdivo currently has regulatory approval in 57 countries including the United States, Japan, and the European Union.  Argos Therapeutics Enters Strategic Research Agreement with Personalis, Inc. DURHAM, NC—Argos Therapeutics Inc. has entered into a strategic research agreement with Personalis, Inc., a precision medicine company, focused on genomics solutions for immuno-oncology, cancer, and genetic disease. Personalis will serve as the primary genomic analysis service provider to support ongoing research efforts to demonstrate that Argos’ lead product candidate, rocapuldencel-T, specifically targets patient-specific neoantigens without the need to identify them first. Argos will utilize the Personalis ACE ImmunoID™ nextgeneration sequencing (NGS) platform to evaluate tumor samples collected during clinical development of Argos’ tumor-specific dendritic cell technology to treat renal cell carcinoma. The analytically validated ACE ImmunoID platform offers the unmatched accuracy through whole exome and transcriptome sequencing for tumor/normal evaluation coupled with leading edge bioinformatics and sample tracking to ensure timely delivery of results including neoantigen identification and tumor mutational burden. “The Personalis technology is a key component to our efforts to further understand the mechanism of action of our lead product, rocapuldencel-T for the treatment of advanced renal cell cancer. We hope to demonstrate that rocapuldencel-T specifically targets neoantigens found only in the patients’ tumors to explain why we observe tumor regression without autoimmunity to the unaffected contralateral kidney,” said Dr. Charles Nicolette, chief scientific officer and vice president of research and development for Argos. Robotic Nephrectomy for Localized RCC On The Rise SAN ANTONIO—Use of robotic radical nephectomy (RRN) to treat stage 1 renal cell carcinoma (RCC) is on the rise in the United States, investigators reported at the Society of Urologic Oncology 17th annual meeting in San Antoni. Using the National Cancer Data Base, Matthew Bream, MD, and colleagues at Case Western Reserve University in Cleveland identified 15,756 patients undergoing minimally invasive radical nephrectomy (RN)—either robotic radical nephrectomy (RRN) or laparoscopic RN (LRN)—for localized T1 RCC from 2010 to 2013. During the 4-year study period, 25% of these patients underwent RRN, with the proportion of cases treated with RRN increasing significantly over time from 18% in 2010 to 31% in 2013, Dr Bream’s group stated in a poster presentation. On multivariable analysis, patients treated at academic hospitals had significant 29% higher odds of undergoing RRN compared with those treated at community hospitals, the investigators reported. Patients with tumor size of 4 cm or less and those who underwent retroperitoneal lymph node dissection had significant 25% and 86% higher odds, respectively, of undergoing RRN.The RRN and LRN groups were similar with respect to perioperative quality indicators and conversion to open surgery. “With similar perioperative quality outcomes and increased attention to health care costs, RRN may face greater scrutiny as a surgical option for localized RCC,” Dr Bream and his colleagues concluded. (continued on page 141)


19544GA
To see the actual publication please follow the link above