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Black Diamond's Lung Cancer Drug Hits 60% Response Rate in Phase 2 Trial

MarketDash Editorial Team
4 days ago
Black Diamond Therapeutics reports impressive Phase 2 results for its lung cancer treatment silevertinib, showing a 60% response rate in patients with hard-to-treat EGFR mutations, while extending its financial runway into 2028 and planning a major glioblastoma trial.

Black Diamond Therapeutics (BDTX) dropped some genuinely interesting Phase 2 data Wednesday for silevertinib, its experimental treatment targeting a tricky subset of lung cancer patients. The results look solid enough that the biotech is now mapping out both partnership conversations and an ambitious expansion into brain cancer.

Here's what happened: The company enrolled 43 frontline non-small cell lung cancer patients with non-classical epidermal growth factor receptor mutations. These aren't your garden-variety EGFR mutations that existing drugs handle reasonably well—they're the oddballs that tend to resist standard treatments. Everyone got 200mg of silevertinib daily, and the company tracked results through early November with a median follow-up of 7.2 months.

The Numbers That Matter

The trial produced 25 confirmed partial responses and one complete response, translating to a 60% objective response rate. That's the headline number, but the central nervous system data might be even more compelling: an 86% CNS response rate and 91% disease control rate. Brain metastases are notoriously difficult to treat in lung cancer, so those figures tend to get oncologists' attention.

On the safety front, Black Diamond didn't see any unexpected problems. The usual suspects showed up—rash, stomatitis, diarrhea, and paronychia—but nothing that derailed the trial or suggested major tolerability issues.

What Comes Next

Black Diamond plans to present more mature data at a medical conference in the second quarter of 2026, including duration of response and progression-free survival figures for both the 43 frontline patients and 83 patients in the recurrent setting. Those metrics will be critical for any potential partnership discussions, which the company says are ongoing as it considers advancing silevertinib into pivotal trials.

The Glioblastoma Gambit

Black Diamond isn't stopping with lung cancer. The company intends to launch a randomized Phase 2 trial in newly diagnosed glioblastoma patients during the first half of 2026. The study will enroll roughly 150 patients, split between a control arm receiving standard temozolomide chemotherapy and an experimental arm getting silevertinib plus temozolomide. Preliminary data should arrive sometime in 2028.

Glioblastoma represents one of oncology's toughest challenges, with dismal survival rates and few treatment advances in recent decades. Whether silevertinib can move the needle there remains very much an open question.

Financial Runway

As of September 30, 2025, Black Diamond reported approximately $135.5 million in cash, cash equivalents, and investments. The company now believes that stash will cover operating expenses and capital requirements into the second half of 2028—a meaningful extension that buys time for both the lung cancer and glioblastoma programs to mature.

BDTX stock dropped 23.77% to $2.62 following the announcement, which seems harsh given the clinical data but probably reflects investors digesting the extended timeline and capital needs ahead.

Back to News

Black Diamond's Lung Cancer Drug Hits 60% Response Rate in Phase 2 Trial

MarketDash Editorial Team
4 days ago
Black Diamond Therapeutics reports impressive Phase 2 results for its lung cancer treatment silevertinib, showing a 60% response rate in patients with hard-to-treat EGFR mutations, while extending its financial runway into 2028 and planning a major glioblastoma trial.

Black Diamond Therapeutics (BDTX) dropped some genuinely interesting Phase 2 data Wednesday for silevertinib, its experimental treatment targeting a tricky subset of lung cancer patients. The results look solid enough that the biotech is now mapping out both partnership conversations and an ambitious expansion into brain cancer.

Here's what happened: The company enrolled 43 frontline non-small cell lung cancer patients with non-classical epidermal growth factor receptor mutations. These aren't your garden-variety EGFR mutations that existing drugs handle reasonably well—they're the oddballs that tend to resist standard treatments. Everyone got 200mg of silevertinib daily, and the company tracked results through early November with a median follow-up of 7.2 months.

The Numbers That Matter

The trial produced 25 confirmed partial responses and one complete response, translating to a 60% objective response rate. That's the headline number, but the central nervous system data might be even more compelling: an 86% CNS response rate and 91% disease control rate. Brain metastases are notoriously difficult to treat in lung cancer, so those figures tend to get oncologists' attention.

On the safety front, Black Diamond didn't see any unexpected problems. The usual suspects showed up—rash, stomatitis, diarrhea, and paronychia—but nothing that derailed the trial or suggested major tolerability issues.

What Comes Next

Black Diamond plans to present more mature data at a medical conference in the second quarter of 2026, including duration of response and progression-free survival figures for both the 43 frontline patients and 83 patients in the recurrent setting. Those metrics will be critical for any potential partnership discussions, which the company says are ongoing as it considers advancing silevertinib into pivotal trials.

The Glioblastoma Gambit

Black Diamond isn't stopping with lung cancer. The company intends to launch a randomized Phase 2 trial in newly diagnosed glioblastoma patients during the first half of 2026. The study will enroll roughly 150 patients, split between a control arm receiving standard temozolomide chemotherapy and an experimental arm getting silevertinib plus temozolomide. Preliminary data should arrive sometime in 2028.

Glioblastoma represents one of oncology's toughest challenges, with dismal survival rates and few treatment advances in recent decades. Whether silevertinib can move the needle there remains very much an open question.

Financial Runway

As of September 30, 2025, Black Diamond reported approximately $135.5 million in cash, cash equivalents, and investments. The company now believes that stash will cover operating expenses and capital requirements into the second half of 2028—a meaningful extension that buys time for both the lung cancer and glioblastoma programs to mature.

BDTX stock dropped 23.77% to $2.62 following the announcement, which seems harsh given the clinical data but probably reflects investors digesting the extended timeline and capital needs ahead.