Black Diamond Therapeutics recently reported positive Phase 2 data for **silevertinib**, its brain-penetrant EGFR inhibitor for frontline NSCLC patients with **EGFR non-classical mutations**.
High-level results from the May update:
* **Preliminary median PFS: 15.2 months**
* **Median DOR not reached**
* **60% ORR**
* **91% disease control rate**
* **86% CNS ORR**
* **No patients developed de novo brain metastases**
* **23/43 patients remained on therapy**, longest at 23.5 months
* Safety looked dose-manageable, with **150mg QD supported for pivotal development**
The company is presenting the data at **ASCO 2026** in an oral presentation, which should give investors more visibility into the durability, CNS activity, and potential pivotal path.
Official results PR: 21 May
[https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-positive-phase-2-results](https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-positive-phase-2-results?utm_source=chatgpt.com)
Webcast replay: 21 May
[https://investors.blackdiamondtherapeutics.com/events/event-details/black-diamond-silevertinib-phase-2-1l-data-update](https://investors.blackdiamondtherapeutics.com/events/event-details/black-diamond-silevertinib-phase-2-1l-data-update)
TipRanks analyst forecast: A lot have reinforced buy since update on
[https://www.tipranks.com/stocks/bdtx/forecast](https://www.tipranks.com/stocks/bdtx/forecast)
Main bull case: if the CNS activity and 15.2m PFS hold up with more follow-up, silevertinib could be more than a niche EGFR drug — potentially a differentiated therapy for a hard-to-treat subset of EGFR-mutant NSCLC.
Worth noting: while the frontline Phase 2 dataset is 43 patients, Black Diamond says **over 200 patients have been treated with silevertinib** across EGFR-mutant NSCLC and EGFR-altered GBM studies, which gives a broader safety/tolerability experience base.
Not financial advice, but I think BDTX is an interesting ASCO watch.