- Single Agent Solid Tumor Clinical Benefit Seen With Tumor Metabolism Inhibitor CB-839
- Continued Signs of Activity, Tolerability, and Durability
The new data to be presented by
“We are very encouraged by these findings in that they reinforce the published safety and efficacy profile of CB-839. We believe that this first partial response in solid tumors points to the potential of our novel agent’s efficacy in renal cell carcinoma, and we look forward to sharing data as our single agent and combination studies mature,” said
The Phase 1 multi-center open label dose escalation study was designed to evaluate the safety and tolerability of CB-839 in locally advanced, metastatic and/or refractory solid tumors. Oral CB-839 was administered in doses of 100 mg to 1000 mg, in 21 day cycles using one of two regimens: TID or BID with food. As of
Safety Data
Among 98 patients evaluable for safety, a maximum tolerated dose has not been established. CB-839 was generally well tolerated with the majority of treatment-emergent adverse events being mild to moderate, Grade 1/2 and reversible. Among patients in the BID with food regimen, 4.5% (3/66) experienced a Grade 3/4 adverse event suspected to be related to CB-839 and 3% discontinued due to drug-related adverse events (2/66). The rate of Grade 3 alanine aminotransferase (ALT) elevations of 1.5% (1/66) in the BID with food cohort was substantially reduced relative to that observed in the TID cohort 16% (5/32).
In addition, a preclinical poster was presented by Calithera’s collaborators. Details for the presentation are as follows:
Targeting glutamine metabolism in colorectal cancers with PIK3CA mutations
Abstract #C115
Zhenghe John Wang, Ph.D., Case Western Reserve University
Poster Session C
About Calithera Biosciences
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the clinical activity, tolerability and unique mechanism of action of CB-839, the safety of CB-839 and the initiation of multiple expansion cohorts in solid tumor types. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's most recent Quarterly Report on Form 10-Q filed with the
CONTACT:Jennifer McNealey ir@Calithera.com 650-870-1071