Will BDTX's EGFR Inhibitor Bring a Paradigm Shift in NSCLC Treatment?

Black Diamond Therapeutics’ BDTX lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM).

Importantly, per BDTX, silevertinib has the potential to treat both newly diagnosed patients with EGFRm NSCLC and those with recurrent disease, due to its ability to target more than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs). Furthermore, it targets the C797S resistance mutation, which can emerge after treatment with AstraZeneca’s AZN Tagrisso (osimertinib), a leading NSCLC drug.

Silevertinib is currently being evaluated in a mid-stage study in patients with EGFRm NSCLC in both the recurrent setting (cohorts 1 and 2) and the frontline setting (cohort 3). The company has completed enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) in July 2025. Initial results from this cohort are anticipated in the fourth quarter of 2025.

The developmental plan for silevertinib includes feedback from the FDA on a potential registrational path in frontline EGFRm NSCLC, anticipated for the first half of 2026, when progression-free survival data from the ongoing Phase II study become available.

The company is currently exploring potential partnerships for the pivotal development of silevertinib in EGFRm NSCLC and GBM.

Given Tagrisso’s dominance in the NSCLC market, the successful development of silevertinib will be a significant boost for BDTX.

Competition for BDTX’s EGFR Inhibitor

AZN’s Tagrisso is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC.

Tagrisso is approved as monotherapy in more than 120 countries, including the United States, the EU, China and Japan.

AZN is evaluating Tagrisso in the early-stage adjuvant resectable setting in the ADAURA2 phase III study.

In August 2024, Johnson & Johnson JNJ obtained FDA approval for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EFGR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Following the approval, JNJ’s Rybrevant plus Lazcluze became the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus Tagrisso approved for the first-line treatment of patients with EGFR-mutated NSCLC.

Earlier, in March 2024, JNJ obtained FDA approval for Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations,based on the phase III PAPILLON study.

BDTX Price Performance, Valuation and Estimates

Shares of BDTX have surged 52.3% year to date compared with the industry’s growth of 4.7%.

From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.40x book value, higher than its mean of 1.31x but lower than the biotech industry’s 3.20x.

The bottom-line estimate for 2025 has moved north to 33 cents in the past 60 days, while that for 2026 has also improved 10 cents to a loss of 82 cents per share.

BDTX currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank  stocks here.


 

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This article originally published on Zacks Investment Research (zacks.com).

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