Clinical Trial News

Genmab announced Phase 1/2 study data of Rina-S, an FRα-targeted ADC, showing a 50% ORR in ovarian cancer patients treated with Rina-S 120 mg/m² Q3W, regardless of FRα expression levels. The study results were presented at ESMO 2024, with Rina-S 120 mg/m² selected for further evaluation in a Phase 3 trial expected to start in 2024.

Pembrolizumab (Keytruda) showed sustained survival benefits over ipilimumab (Yervoy) in unresectable stage III or IV melanoma patients, with 10-year follow-up data from the KEYNOTE-006 study presented at the 2024 ESMO Congress. Pembrolizumab had a median overall survival (OS) of 32.7 months vs 15.9 months for ipilimumab, with 8- and 10-year OS rates of 36.9% and 34.0% vs 24.8% and 23.6%, respectively. The study also highlighted the safety profile and long-term efficacy of pembrolizumab, supporting its standard of care status in advanced melanoma.

Updated data for Nectin-4 targeting zelenectide pevedotin in mUC showed a 45% ORR, 11.1 months median duration of response, and a well-tolerated safety profile. EphA2-targeting BT5528 demonstrated a 45% ORR in mUC and a differentiated safety profile. Low frequency and severity of treatment-related peripheral neuropathy were observed with zelenectide pevedotin and BT5528. BT7480 showed favorable safety and preliminary antitumor activity in advanced Nectin-4-associated solid tumors.

Alphamab Oncology presented JSKN003's clinical data at ESMO Congress 2024, showing promising efficacy and safety in platinum-resistant ovarian cancer and advanced HER2-positive solid tumors, supporting further clinical exploration.

The FDA approved OCREVUS ZUNOVO™, a twice-a-year subcutaneous injection for relapsing and primary progressive multiple sclerosis, offering more treatment options. This approval is supported by a decade of safety and efficacy data from Ocrevus® IV, with over 350,000 people treated globally. OCREVUS ZUNOVO™ provides flexibility in treatment administration, potentially expanding access to those without IV infrastructure.

Updated MARIPOSA-2 study results show amivantamab plus chemotherapy significantly improves post-progression outcomes and overall survival in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, compared to chemotherapy alone.

Luveltamab tazevibulin (luvelta) + bevacizumab showed 56% ORR in late-stage ovarian cancer at RP2D, with 35% overall response rate. No new safety signals were observed. Expansion at RP2D ongoing with 23 additional patients enrolled; data expected in H1 2025.

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RP1 (vusolimogene oderparepvec) combined with nivolumab (Opdivo) showed durable antitumor activity and a favorable safety profile in advanced melanoma patients who progressed on anti–PD-1 therapy, with a 33.6% overall response rate and a 15.0% complete response rate. The median duration of response was 21.6 months, and most treatment-related adverse events were grade 1 or 2. A phase 3 trial, IGNYTE-3, is underway to further evaluate this combination.

SPRINT and ACCORD-BP trials pooled for post-hoc analysis; SPRINT tested intensive BP control (SBP < 120 mmHg) vs. standard (SBP < 140 mmHg) in high CVD risk non-DM participants, while ACCORD-BP used a 2x2 factorial design in high CVD risk DM participants. Outcome of interest was stroke-free survival (SFS), analyzed using Kaplan-Meier curves and Cox proportional hazards models. Data available at https://biolincc.nhlbi.nih.gov.