Achieved confirmed responses in melanoma patients progressing on PD-1/PD-L1 therapy
"This trial is designed to include patients who are currently receiving checkpoint inhibitor therapy and experiencing disease progression at the time of enrollment. There is significant unmet need among these patients, and the responses observed would not be expected with treatment with Opdivo® alone in this population," said
Calithera is conducting a Phase 1/2 trial (NCT02771626) in collaboration with
The ongoing study enrolled three cohorts of patients who have received a checkpoint inhibitor (PD-1/PD-L1) in the most recent line of therapy.
- Among 16 evaluable melanoma patients, all of whom were progressing on a checkpoint inhibitor at study entry, one patient achieved a complete response and two patients achieved partial responses. The overall response rate in this cohort was 19%, and the overall disease control rate was 44%.
- Among six evaluable non-small cell lung cancer patients, all of whom were progressing on a checkpoint inhibitor at study entry, 67% experienced stable disease.
- Among eight evaluable renal cell carcinoma patients, 75% were progressing and 25% had stable disease at study entry. Stable disease was achieved in 75%, all of whom were progressing on a checkpoint inhibitor at study entry.
The study enrolled one cohort of renal cell carcinoma patients who have received a checkpoint inhibitor in any prior line of therapy, but never achieved a response to checkpoint therapy.
- Among seven evaluable checkpoint inhibitor experienced renal cell carcinoma patients, with a median of four prior lines of therapy, 57% experienced stable disease.
The study enrolled one cohort of renal cell carcinoma patients who were previously treated with VEGF inhibiting therapy, and were naïve to checkpoint inhibitors.
- Among 19 evaluable checkpoint inhibitor naïve renal cell carcinoma patients, four patients (21%) achieved a partial response and disease control rate was 74%. Fifty percent of the enrolled patients remain on study treatment.
An analysis of all safety evaluable patients demonstrated that CB-839 was well tolerated when combined with Opdivo® in melanoma, renal cell carcinoma and non-small cell lung cancer patients. During dose escalation of the combination therapy, there was one report of dose limiting Grade 3 ALT increase, however no maximum tolerated dose was reported. The majority of adverse events reported have been mild to moderate with the most common being fatigue, nausea and photophobia. With 3.7% immune-related adverse events Grade ≥ 3, the data suggest there was no apparent increase in the rate or severity of immune related events compared to historical rates.
Calithera will webcast a clinical update on CB-839 on
Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.
Calithera is a clinical-stage biopharmaceutical company focused on fighting cancer by discovering, developing, and commercializing novel small molecule drugs that target tumor and immune cell metabolism. Calithera is headquartered in
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 safety, tolerability and efficacy of CB-839, Calithera’s plans to continue development of CB-839 in combination therapy for clear cell renal cell carcinoma, the potential for combining nivolumab (marketed as Opdivo®) withCB-839 to drive improved and sustained efficacy in clear cell renal cell carcinoma and other cancers, including NSCLC and melanoma, and the advancement of CB-839 in clinical trials. 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 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
Source: Calithera Biosciences, Inc.