BriaCell Doubles PFS, Shares Clinical Data at ASCO 2024

7 June 2024

BriaCell Therapeutics Corp., a clinical-stage biotechnology company, recently shared encouraging clinical data for its lead product, Bria-IMT™, aimed at treating heavily pretreated advanced breast cancer patients with CNS metastases. The findings were highlighted during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 31 to June 4 in Chicago, IL.

The company’s clinical study demonstrated that Bria-IMT™ achieved an 83% intracranial objective response rate (iORR) among patients with brain metastases, a significant milestone for those who have undergone extensive prior treatments. This was accompanied by a median progression-free survival (PFS) of 4.1 months for patients resistant to antibody-drug conjugates (ADCs), doubling the PFS seen in comparable studies. In addition, a clinical benefit rate (CBR) of 55% was noted in evaluable patients, significantly higher than reported in similar research.

The clinical trial data was presented by Dr. Saranya Chumsri, a Principal Investigator and Professor of Oncology at the Mayo Clinic, alongside two poster sessions and one abstract. The studies included 54 patients with advanced metastatic breast cancer who had failed multiple prior treatments, including ADCs and immune checkpoint inhibitors (CPIs). The patients had undergone a median of six previous treatments.

Key efficacy outcomes from the trial included a progression-free survival (PFS) of 3.9 months for patients treated with the planned pivotal Phase 3 formulation of Bria-IMT™, compared to similar studies where patients received their physician’s treatment of choice. An overall response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55% were observed in evaluable patients, surpassing the outcomes from other studies.

Dr. Sara A. Hurvitz, a member of BriaCell's medical advisory board and Professor of Medicine at Fred Hutchinson Cancer Center and the University of Washington, emphasized the critical need for novel, well-tolerated, and effective treatments for patients with heavily pretreated metastatic breast cancer. The promising early data from BriaCell's study suggest a potential breakthrough in cancer care, pending further confirmation in larger clinical trials.

Dr. Adam M. Brufsky, another advisory board member and Professor of Medicine at the University of Pittsburgh School of Medicine, highlighted the potential of Bria-IMT™ as a novel therapeutic capable of addressing significant challenges in managing progressive metastatic breast cancer. The encouraging preliminary activity in a refractory patient setting underlines the potential impact of Bria-IMT™.

BriaCell’s Chief Medical Officer, Dr. Giuseppe Del Priore, expressed excitement over the four published abstracts and an oral presentation at the ASCO meeting, underscoring it as a pivotal event for the company. The promising updated data from the Phase 2 study indicate clinical efficacy across all patient groups and a preferred safety profile.

The safety of Bria-IMT™ was also highlighted, with no discontinuations related to the treatment and no occurrence of interstitial lung disease (ILD), a common serious adverse event with ADCs. The absence of these issues underlines Bria-IMT™'s favorable tolerability and safety profile.

In conclusion, BriaCell Therapeutics has observed improved progression-free survival and clinical benefits in heavily pretreated advanced breast cancer patients, in contrast to data from similar studies. The company plans to continue monitoring these clinical responses in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer. The results from this study could potentially transform the therapeutic landscape for patients with this condition.

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