ENTRATA Study: Is the improvement in progression-free survival clinically meaningful? #ESMO19

Chung-Han Lee, MD @ChungHanLee3 of @sloan_kettering explains questions asked by his colleagues: was the improvement in progression-free survival clinically meaningful?

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Data shared today in oral presentation at ESMO Congress 2019 show telaglenastat doubles median progression-free survival (PFS) in heavily pre-treated patients with advanced disease, reduced risk of death by 36% (HR=0.64, p=0.079 one-sided)

 

First glutaminase inhibitor to demonstrate clinical activity for treatment of cancer

 

SOUTH SAN FRANCISCO, Calif., Sept. 28, 2019 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, presented today supporting data for its previously reported positive results from its randomized placebo-controlled Phase 2 ENTRATA study of telaglenastat (CB-839) in combination with everolimus in patients with advanced renal cell carcinoma (RCC). The telaglenastat-everolimus combination doubled the median progression-free survival (PFS) in heavily pre-treated patients with advanced RCC and had a well-tolerated safety profile. Telaglenastat is the first glutaminase inhibitor to demonstrate clinical activity for the treatment of cancer.

 

Calithera announced top-line results from the ENTRATA trial in June. Data from the study were accepted as a late-breaker abstract and will be shared for the first time this morning during an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain (#LBA54).

 

“Outcomes for late-line metastatic renal cell carcinoma are often poor using currently available medications with similar mechanism of action,” said Chung-Han Lee, MD, PhD, Memorial Sloan Kettering Cancer Center, who will present the data. “New treatments with novel mechanisms of action are greatly needed for this patient population. The results from the randomized ENTRATA trial demonstrate activity of telaglenastat in RCC and provide proof of concept for glutaminase inhibition as a new mechanism of action that may improve outcomes for patients with this disease.”

 

“We continue to be encouraged by these data, which suggest that glutaminase inhibition – and telaglenastat in particular – could offer advanced RCC patients a novel therapeutic option,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “ENTRATA demonstrates a clinically meaningful improvement in progression-free survival among patients with advanced disease who have been treated with many prior lines of therapy. We are evaluating telaglenastat in the ongoing CANTATA trial in combination with cabozantinib for patients with advanced clear cell RCC, and we look forward to learning how telaglenastat performs in this setting.”

Read here: https://www.oncologytube.com/video/data-from-randomized-phase-2-entrata-study-demonstrate-telaglenastat-with-everolimus-improves-progression-free-survival-in-renal-cell-carcinoma