FDA Grants Fast Track Designation to BDTX-189 to Treat Allosteric HER2 or EGFR Mutations


Black Diamond Therapeutics announced that the FDA granted fast track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation.

The FDA granted fast track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation, an EGFR, or HER2 Exon 20 insertion mutation, according to a Black Diamond Therapeutics press release.

BDTX-189 is an orally available, irreversible small molecule inhibitor for patients who have progressed following prior treatment and who have no satisfactory treatment options.

“While targeted therapies, such as kinase inhibitors, have transformed the treatment of cancer, only a small percentage of patients with metastatic cancer have tumors with genetic profiles that could make them eligible for an approved precision oncology medicine,” David M. Epstein, PhD, president and chief executive officer of Black Diamond Therapeutics, said in a press release.

The MasterKey-01 trial is a phase 1/2 open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of BDTX-189 for patients with no standard therapy available.

The 2-part trial will feature a phase 1 open-label dose escalation study to determine the recommended phase 2 dose and schedule in up to 88 patients with the allosteric HER2 mutation, EGFR, or HER2 exon 20 insertion mutations.

Phase 2 is an open-label, multicenter basket study to determine antitumor activity and safety in adult patients of the same mutation cohort. The second part of the study will utilize a Simon 2-stage design and enroll up to 100 patients in 4 cohorts.

Those groups include non-small cell lung cancer with EGFR or HER2 exon 20 insertion mutations; breast cancer with an allosteric ErbBmutation; solid tumors (except breast) with S310F/Y mutation; and other tumors harboring allosteric ErbBmutations not included in cohorts 1-3.

“The FDA’s decision to grant Fast Track designation is an important recognition of BDTX-189’s potential to treat patients with currently unaddressed oncogenic mutations in EGFR and HER2,” said Epstein in a press release. “We look forward to working closely with the FDA as we continue to enroll and dose patients in the MasterKey-01 trial, our Phase 1/2 clinical study of BDTX-189, as part of our mission to discover and develop novel, tumor-agnostic, precision oncology therapies for genetically defined cancers.”

BDTX-189 is designed to selectively inhibit the activity of previously unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2. As it stands, there are no drugs approved by the FDA to address these oncogenic driver mutations with a single therapy.


Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation [news release]. Cambridge, Massachusetts. Published July 28, 2020. https://www.globenewswire.com/news-release/2020/07/28/2068559/0/en/Black-Diamond-Therapeutics-Granted-Fast-Track-Designation-by-the-FDA-for-BDTX-189-for-the-Treatment-of-Adult-Patients-with-a-Solid-Tumor-Harboring-an-Allosteric-HER2-Mutation-or-an.html. Accessed July 28, 2020.

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