Black Diamond Therapeutics doses first patient in Phase 1 study focused on non-small cell lung cancer NSCLC and glioblastoma

Black Diamond Therapeutics (Nasdaq: BDTX) has announced that it has dosed the first patient in the Phase 1 study focused on BDTX-1535.

BDTX-1535 is a MasterKey inhibitor of epidermal growth factor receptor (EGFR) to potentially treat non-small cell lung cancer (NSCLC) and glioblastoma (GBM).

Cambridge, Massachusetts–based Black Diamond believes BDTX-1535 holds significant potential for EGFR-mutant NSCLC and GBM.

“This is the second MasterKey inhibitor derived from our MAP drug discovery engine; we are incredibly excited about BDTX-1535’s advancement into the clinic, and we look forward to providing a clinical update in the second half of 2023,” said David M. Epstein, CEO of Black Diamond Therapeutics.

“Despite recent successes in targeting EGFR-mutated NSCLC, there is still a need for better therapeutics for patients with disease progression following first-line EGFR inhibitors,” said Dr. Melissa Johnson, director of lung cancer research for Sara…

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Hutchmed and AstraZeneca launch Phase 3 to test Orpathys and Tagrisso in lung cancer

Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).

Specifically, the study will focus on patients with amplification of the MET gene who have had disease progression after receiving EGFR inhibitor therapy.

In June, Orpathys from AstraZeneca and HutchMed won conditional approval in China for patients with lung cancer with MET exon 14 skipping alterations. The drug is an oral MET tyrosine kinase inhibitor (TKI).

FDA and the E.U. first approved AstraZeneca’s Tagrisso in 2018. The drug is an irreversible epidermal growth factor receptor TKI. Last year, the drug brought in $4.32 billion in international revenue.

AstraZeneca and HutchMed dosed the first patient in the SACHI study


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AstraZeneca’s Imfinzi and tremelimumab show promise in non-small cell lung cancer study

AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON.

Imfinzi and tremelimumab are immune checkpoint inhibitors.

“The POSEIDON data offer patients further benefit from Imfinzi and are an important validation of our development strategy to explore novel combinations,” said Susan Galbraith, AstraZeneca’s executive vice president, oncology R&D.

Imfinzi is a human monoclonal antibody that targets programmed death-ligand 1 (PD-L1).

While many Big Pharma firms have developed PD-L1 drugs, few have become blockbusters — Bristol Myers Squibb’s Yervoy (ipilimumab) is one exception.

The POSEIDON trial had 338 recipients who received Imfinzi, tremelimuma…

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FDA approves Janssen’s Rybrevant for subset of non-small cell lung cancer

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy.

The agency also approved the Guardant360 CDx from Guardant Health as a companion diagnostic for Rybrevant.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence, in a statement. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

[Related: 25 promising pipeline drugs]<…

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