CLINICAL AND REGULATORY
FDA approved Datroway for patients with pre-treated advanced EGFR-mutated NSCLC
Datroway (Dato-DXd) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on ORR and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The approval follows Priority Review and Breakthrough Therapy Designation by the FDA based on results from a subgroup analysis of the TROPION-Lung05 Phase 2 trial and supported by data from the TROPION-Lung01 Phase 3 trial. In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95% CI: 35-54) in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (n=114) as assessed by BICR. Complete responses were seen in 4.4% of patients and partial responses were seen in 40% of patients. The median DoR was 6.5 months (95% CI: 4.2-8.4).
ADCT announced updated Zynlonta data in marginal zone lymphoma presented at ICML
ADC Therapeutics announced updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of Zynlonta to treat relapsed/refractory marginal zone lymphoma presented during a poster session at the International Conference on Malignant Lymphoma (ICML) in Lugano. The single-arm, open-label, study is led by Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine. As of February 10, 2025, a total of 27 adult patients with r/r MZL and previously treated with ≥1 line of systemic therapy were enrolled with 26 patients evaluable for response. Highlights of the data include ORR of 84.6% (22/26); complete response (CR) rate of 69.2% (18/26). Among POD24 patients assessed for response, a CR rate of 61.5% (8/13) was observed. CR was maintained in 17 of 18 CR patients who achieved CR, with longest duration of CR of 27 months from start of treatment. PFS was 92.9% at 12 months. 27 enrolled patients experienced adverse events, consistent with the known safety profile of Zynlonta and most commonly grade 1 or 2. Grade 3 and 4 AEs were observed in 16 and 2 patients, respectively and included neutropenia, RSV lung infection and hyponatremia (with 2 AEs occurring in the same patient). Three patients needed dose reduction, and one patient discontinued treatment after cycle 4 due to cholestatic hepatitis that fully recovered
Lilly presented first clinical data for its FRα targeting ADC in platinum-resistant ovarian cancer
Eli Lilly announced new Phase 1 data showing that its FRα ADC LY4170156 demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine. A preliminary ORR of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. Lilly's FRα targeting ADC is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a TOPO1 inhibitor, via a proprietary cleavable polysarcosine linker. The data were presented at ASCO. As of the March 9, 2025 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 - 6 mg/kg). Patients received a median of five prior systemic regimens. Efficacy results demonstrate responses at all dose levels, across all FRα expression levels. In the 58 efficacy-evaluable patients (37 patients remain ongoing prior to first response assessment and were therefore not yet efficacy-evaluable at the time of the data cutoff), the ORR was 45% (26/58 patients), and the disease control rate was 74% (43/58). At the potential recommended Phase 2 dose of 4 mg/kg, the ORR was 55% (11/20 patients). The most common treatment-emergent adverse events across all dose levels included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%).
DEALS AND FINANCING
OBI Pharma entered ADC collaboration with TegMine utilizing GlycOBI and TegMiner
OBI Pharma and TegMine Therapeutics, a US Biopharma specialized in developing best-in-class antibodies targeting cancer glycans and glycoproteins, have entered into an ADC-related Master Services Agreement. OBI grants TegMine rights to utilize OBI’s GlycOBI ADC enabling technologies, powered by EndoSymeOBI and HYPrOBI, to identify ADC therapeutics candidates for potential clinical development. If an ADC product candidate is ensued, OBI and TegMine would enter into a formal licensing agreement.