Impressive preliminary objective response rates in NSCLC and EGFRmut NSCLC: Interim results of a Phase 1 study of BC3195
- BioCity presented interim results of its Phase 1 study of BC3195 at ESMO 2024.
- BC3195 showed an ORR of 36.4% in NSCLC and 80% in EGFRmut NSCLC.
- The study enrolled 34 patients, with dose levels ranging from 0.3 to 2.4 mg/kg IV Q3W.
- Notable safety findings included Grade 3 pharyngitis, rash, stomatitis, and liver function abnormalities.
- BioCity plans to continue dose optimization and patient accrual in NSCLC, breast cancer, and other CDH3-expressing cancers.
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Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial
- The TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in the final overall survival (OS) analysis.
- The trial previously met the dual primary endpoint of progression-free survival (PFS) with significant improvement.
- The safety profile was consistent with previous analyses, showing lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy.
- The data will be presented at a forthcoming medical meeting and shared with regulatory authorities currently reviewing applications for this indication.
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IDEAYA Biosciences announces positive interim phase 2 data for darovasertib and successful FDA type C meeting on registrational trial design for regulatory approval in neoadjuvant uveal melanoma
- Phase 2 data shows ~49% of patients with >30% tumor shrinkage and ~61% eye preservation rate.
- FDA Type C meeting supports registrational trial design with primary endpoints of eye preservation and time to vision loss.
- Potential Phase 3 trial to enroll ~400 patients, targeting initiation after finalizing protocol with FDA.
- Annual incidence of primary UM in North America, Europe, and Australia is projected to be ~12k patients.
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Black Diamond Therapeutics announces initial phase 2 data demonstrating robust anti-tumor activity of BDTX-1535 in patients with recurrent EGFRm NSCLC
- BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed.
- Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations.
- Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment.
- Regulatory feedback on registration path anticipated in Q1 2025.
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Merck receives positive EU CHMP opinions for Keytruda regimens in gynecologic cancers
- The European Medicines Agency’s CHMP recommended approval of Keytruda for two gynecologic cancer indications.
- First recommendation: Keytruda with carboplatin and paclitaxel for first-line treatment of advanced or recurrent endometrial carcinoma.
- Second recommendation: Keytruda with chemoradiotherapy for FIGO Stage III-IVA locally advanced cervical cancer.
- The European Commission will review these recommendations, with decisions expected in Q4 2024.
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Innate Pharma announces FDA clearance of the IND for IPH4502, a Nectin-4 ADC to be developed in solid tumors
- Innate Pharma received FDA clearance for its IND application to initiate a Phase 1 clinical study of IPH4502.
- IPH4502 is a novel topoisomerase I inhibitor ADC targeting Nectin-4 in solid tumors.
- The Phase 1 study will include dose escalation and dose optimization parts, assessing safety, tolerability, and preliminary efficacy.
- The study will focus on advanced solid tumors expressing Nectin-4, including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, and colorectal cancers.
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Elevation Oncology receives fast track designation from the FDA for EO-3021
- Elevation Oncology's EO-3021 granted Fast Track designation by the FDA for advanced or metastatic gastric and gastroesophageal junction cancer expressing Claudin 18.2.
- The designation is based on nonclinical and initial clinical data from an ongoing Phase 1 trial, showing a 42.8% overall response rate in a Claudin 18.2-enriched subset.
- EO-3021 is a differentiated antibody drug conjugate (ADC) targeting Claudin 18.2 with a monomethyl auristatin E (MMAE) payload.
- Next steps include monotherapy dose expansion and additional data reporting in the first half of 2025, with the combination portion of the study starting later this year.
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BioAtla and Context Therapeutics announce exclusive worldwide license agreement to develop and commercialize BA3362
- Context Therapeutics obtains exclusive rights to develop and commercialize BA3362, a Nectin-4 x CD3 T cell engaging antibody.
- BioAtla to receive $15 million upfront and near-term milestones, with potential additional payments up to $118.5 million, plus royalties.
- Context plans to file an IND for BA3362 in mid-2026.
- BioAtla will focus on its lead clinical CAB programs while Context handles BA3362 development.
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Henlius receives positive CHMP opinion for Hansizhuang as first-line treatment for extensive-stage small cell lung cancer
- Hansizhuang (serplulimab) is the first anti-PD-1 mAb for first-line treatment of ES-SCLC.
- The CHMP of the EMA issued a positive opinion recommending approval of Hansizhuang.
- The opinion is based on the ASTRUM-005 study, a randomized, double-blind, placebo-controlled trial.
- Hansizhuang has already been approved in China, Indonesia, Cambodia, and Thailand.
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Repare Therapeutics announces new data underscoring need for additional treatment solutions for patients with metastatic gynecologic cancers
- Repare Therapeutics presented new data on alterations in FBXW7, PPP2R1A, and CCNE1 in metastatic ovarian and endometrial cancers.
- The data, shared at AACR's 15th Annual Ovarian Cancer Research Symposium, highlight chemotherapy resistance and lack of treatment options for these patients.
- Repare's Phase 1 MYTHIC trial is evaluating lunresertib and camonsertib in patients with these biomarkers, with data expected in Q4 2024.
- Patients with these biomarkers show significantly lower median overall survival compared to those without.
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