On April 11, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported a summary of clinical and preclinical data reviewed during the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in New Orleans, Louisiana from April 8-13, 2022 (Press release, Zentalis Pharmaceuticals, APR 11, 2022, View Source [SID1234611965]).
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Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis, commented, "The data presented at AACR (Free AACR Whitepaper) demonstrate the encouraging anti-tumor activity and tolerability of our potentially best-in-class candidates across our pipeline. Following the positive initial data of ZN-c3 in combination with chemotherapy in advanced ovarian cancer patients reviewed at AACR (Free AACR Whitepaper), today we presented a mini symposium presentation on our Phase 1 expansion cohort of ZN-c3 in USC patients. ZN-c3 showed robust clinical activity in an advanced, sicker patient population (57% had prior pembrolizumab/lenvatinib use), specifically demonstrating a deepening of tumor response, which included one patient who achieved an unconfirmed complete response. We believe ZN-c3’s anti-tumor activity and tolerability profile observed to date has the potential to address a significant unmet need for improved therapeutic options in advanced USC patients."
Recap of Clinical and Preclinical Updates Presented During AACR (Free AACR Whitepaper)
Advanced ovarian cancer – Initial update from the Phase 1b trial of ZN-c3 in combination with chemotherapy
As of the January 28, 2022, data cutoff (n=43 evaluable), ZN-c3 in combination with chemotherapy demonstrated strong anti-tumor activity in a heavily pretreated population, with an Objective Response Rate (ORR) of 30.2% across all evaluable chemotherapy cohorts – achieving up to 62.5% with one cohort (n=8 evaluable).
ZN-c3 in combination with chemotherapy was well-tolerated and exhibited lower hematologic toxicity and a better gastrointestinal tolerability profile in a cross-trial comparison to the Wee1 inhibitor class.
Uterine serous carcinoma – Interim data from the Phase 1 monotherapy expansion cohort in patients dosed ≥300mg QD was presented at a mini symposium earlier today:
As of the January 21, 2022 data cutoff (n=11 evaluable), ZN-c3 demonstrated an ORR of 27.3%, a Disease Control Rate (DCR) of 90.9% and included one subject who achieved an unconfirmed complete response.
In a cross-trial comparison, the overall safety profile of ZN-c3 suggests that it is better tolerated than a competing Wee1 inhibitor.
Preclinical poster updates
The three posters demonstrated the broad potential of ZN-c3 in multiple settings including AML, PARP-resistant ovarian cancer, and in novel biology when combined with Zentalis’ BCL-2 inhibitor, ZN-d5.
CAMPRO – CAspase Mediated PROteolysis (CAMPRO) describes novel biology elucidated by Zentalis that demonstrates the synergy between BCL-2 and Wee1 inhibition. Zentalis is the only company to have both a Wee1 inhibitor (ZN-c3) and a BCL-2 inhibitor (ZN-d5) in clinical development.
These findings further support ZN-c3 as a potential cornerstone treatment, creating a significant market opportunity across a broad range of solid and liquid tumors.