Black Diamond Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference
Review the key takeaways and the transcript of this earnings call.
- Black Diamond Therapeutics is developing silivertinib, a CNS-penetrant eGFR inhibitor for a broad spectrum of oncogenic eGFR mutations in non-small cell lung cancer and glioblastoma.
- In a frontline cohort of 43 newly diagnosed patients with eGFR-mutated non-small cell lung cancer and non-classical mutations, silivertinib produced a confirmed overall response rate of 60% and median progression-free survival of just over 15 months.
- The cohort included 33 unique non-classical mutations and 19 patients, or 44%, with baseline brain metastases.
- Silivertinib produced an 86% confirmed CNS overall response rate in patients with brain metastases, and no patient developed a de novo brain metastasis on study.
- Management said confirmed responses have been observed across 29 unique types of eGFR mutations.
- Black Diamond initiated a randomized phase two study of silivertinib in newly diagnosed glioblastoma patients with MGMT unmethylated status, comparing temozolomide with temozolomide plus silivertinib.
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Transcript
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Anytime when you're ready. Oh, perfect.
Okay. Welcome to our next Fireside Chat.
I'm Robert Burns, managing director and senior biotech analyst at H.C. Wainwright. I'm joined today by Elizabeth Buck, the CSO of Black Diamond Therapeutics. Liz, thank you for joining us today.
Thank you for having me.
For those who might not be familiar with Black Diamond, can you provide a brief overview of the company and its pipeline?
Yeah. We're a company focused on precision medicine in oncology. Specifically, we are developing silevertinib, a best-in-class EGFR inhibitor, a CNS-penetrant EGFR inhibitor, positioned against a broad spectrum of oncogenic EGFR mutations. Our development is focused on both non-small cell lung cancer as well as in glioblastoma. Our most recent data release was at ASCO Conference this year, where we described our frontline data for silevertinib in patients with EGFR mutated non-small cell lung cancer, those patients presenting with what we'll describe as non-classical oncogenic driver mutations. With that positive data in hand, we are now going to the FDA for discussions on pivotal development strategy. Also in development in the setting of glioblastoma, where we initiated a phase II trial in newly diagnosed EGFR mutated patients, just this past spring.
Yeah. When we think about the EGFR mutational landscape, obviously it sort of goes into three buckets, right? You got the classical, the exon 19, exon 21, but then you got the exon 20 insertion mutations, and then this other bucket of atypical.
Yeah PACC sort of looped in there.
Maybe provide some color for investors because obviously, the different mutational profiles here, different treatment approaches for each of those mutational profiles.
It can get quite complex for an investor who's not really in the weeds with the science. Maybe talk to us a little bit about the epidemiology of these atypical mutations and how are they typically treated?
Yeah. First and foremost, in non-small cell lung cancer, there's a group of mutations which we call non-classical oncogenic driver mutations. These mutations comprise roughly a quarter of all patients newly diagnosed with EGFR mutated non-small cell lung cancer. Now included in this bucket are groups of mutations that are sometimes in the literature referred to as atypical mutations, uncommon mutations. About half of those mutations fall into a category which is termed PACC mutations.
PACC is just a subset of the full spectrum of Yeah non-classical mutations.
There are many additional mutations in conjunction with PACC mutations. When we consider silevertinib is active against both the classical EGFR mutations, L858R or an exon 19 deletion, in addition to this quarter of that space, which is non-classical oncogenic driver mutations. In clinical study, we have demonstrated confirmed radiographical responses in 29 unique types of those mutations.
Yeah. The broadest spectrum that is really reported among EGFR inhibitors.
The other aspect, when we consider for these mutations and what is standard of care for this patient population, I think it is important to note that these patients with non-classical oncogenic driver mutations are especially prone to brain metastases.
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