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…
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…
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…
Lorbrena wins expanded indications for lung cancer
Lorbrena from Pfizer was initially FDA indicated to treat adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive based an FDA-approved test. In March, Pfizer announced that the drug had won an expanded indication for use as a first-line therapy for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell…
Roche’s tumor-agnostic therapy Rozlytrek gaining traction
ROZLYTREK from Roche‘s Genentech division is FDA-indicated for adult patients with metastatic non-small cell lung cancer whose tumors are ROS1-positive. In addition, it is indicated for adults and children 12 and older with solid tumors. The latter indication requires that the tumors have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation. Other requirements…
Gavreto is FDA-approved for RET-altered thyroid cancers
FDA has indicated Gavreto (pralsetinib) from Blueprint Medicines to treat adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The drug was formerly known as BLU-667 and won FDA approval in September 2020. CStone, which is developing the drug in China, received approval from that country’s regulatory authority, making it the first novel therapy for…
Xospata met primary endpoint in confirmatory trial
Xospata (gilteritinib) from Astellas Pharma is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. In March, Astellas announced that the drug met its primary endpoint in a planned interim analysis of a Phase 3 confirmatory…
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…