New Antibody for HER2+ MBC Shows similar Efficacy to H&P

Anonymous

https://www.practiceupdate.com/c/128062/67/13/?elsca1=emc_enews_weekinreview&elsca2=email&elsca3=practiceupdate_metastaticbreastcancer&elsca4=metastaticbreastcancer&elsca5=newsletter&rid=NDcyNTI4MzY5MTA0S0&lid=20849614

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• This first-in-human, phase I study of KN026, a novel HER2-targeted bispecific antibody, showed promising efficacy for the treatment of patients with HER2-positive metastatic breast cancer. The objective response rate was 28.1%, with a median progression-free survival of 6.8 months in a heavily pretreated population. Treatment was well-tolerated with mostly grade 1–2 adverse events. The most common adverse events were pyrexia, diarrhea, and transaminitis.
• The efficacy of KN026 was similar to that of trastuzumab and pertuzumab in this population. Co-amplification of CDK12 might be a promising biomarker in predicting the response to KN026.

“Significant progress has been made in treating HER2-positive metastatic breast cancer, leading to the availability of eight approved targeted therapies. As a result, outcomes have improved, with patients living longer while maintaining a good quality of life. Accordingly, there continues to be an unmet need for the development of further novel therapies. Bispecific antibodies are monoclonal antibodies that target two different epitopes, enabling inhibition of multiple oncogenic pathways to force the connection between the cancer and the immune cells. The current study presents early data for one such agent, KN026. Over half the patients had received a median of three or more prior lines of therapy in the metastatic setting, and 84% had visceral disease. Virtually all patients (97%) had received prior trastuzumab and pertuzumab, 51% had received a prior TKI, and 24% had received an antibody–drug conjugate. As such, these patients represented those we are commonly seeing in clinic. At the recommended phase II dose, preliminary efficacy was encouraging and treatment was well-tolerated. Translational data confirmed that co-amplification of CDK12 was a promising biomarker for activity. It is encouraging to see activity of novel therapies in heavily pretreated patients with HER2-positive metastatic breast cancer, which will hopefully lead to approval of more treatment options.“

LoriCA

Important to pay attention this part because that's a huge difference -

"Translational research in 20 HER2-amplified patients further confirmed that co-amplification (vs. no co-amplification) of CDK12 was a promising biomarker in predicting better response to KN026 (ORR of 50% vs. 0% and median PFS of 8.2 vs. 2.7 months, P = 0.05 and 0.04, respectively)."