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Calithera (CALA) Completes Enrollment in Mid-Stage RCC Study

Zacks Equity Research

Calithera Biosciences, Inc. CALA announced that it has completed patient enrollment in the phase II study – CANTANA. This study is evaluating its lead candidate, telaglenastat (previously CB-839), in combination with Exelixis, Inc.’s EXEL Cabometyx (cabozantinib) for treating advanced kidney cancer.

The CANTANA study is evaluating the combination regimen in patients with advanced or metastatic renal cell carcinoma (“RCC”), a form of kidney cancer, who have received one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of Bristol-Myers’ BMY Opdivo (nivolumab) and Yervoy (ipilimumab). Top-line data from the study is expected in the second half of 2020.

Calithera’s telaglenastat was granted Fast Track designation for metastatic RCC in 2018.

Earlier this year, the company announced top-line data from another phase II study – ENTRATA – which evaluated telaglenastat in combination with everolimus in patients with advanced RCC. Data showed that the combination regimen met the primary endpoint of improving progression-free survival.

Apart from RCC, Calithera is also developing telaglenastat in other oncology indications. The company has collaboration with Bristol-Myers to develop telaglenastat in combination with Opdivo as a potential treatment for RCC, melanoma and non-small cell lung cancer (NSCLC). Calithera also has collaboration with Pfizer PFE to develop telaglenastat in combination with Pfizer’s Talzenna or Ibrance for treating RCC, triple negative breast cancer, colorectal cancer and NSCLC.

At present, Calithera has two other clinical-stage candidates, INCB001158 and CB-280, in its pipeline. The company is developing CB-1158 in several phase I/II studies as monotherapy or in combination with Merck’s Keytruda or a chemotherapy targeting solid tumors under a collaboration with Incyte Corporation. A phase I study is evaluating CB-280 as a potential treatment for cystic fibrosis.

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