Daishin Securities announced on the 10th that Yuhan Corporation was selected as the 2024 Best of ASCO after presenting superior clinical results compared to the existing intravenous formulation.
Lee Hee-young, a researcher at Daishin Securities, reported on the same day, “At the 2024 ASCO, Janssen presented the results of the Phase 3 PALOMA-3 clinical trial comparing the subcutaneous formulation of Lazertinib + Amivantamab SC (subcutaneous injection) and the intravenous formulation Lazertinib + Amivantamab IV (intravenous injection) in patients with EGFR mutation-positive non-small cell lung cancer who had prior treatment history.”
Researcher Lee explained, “When changing from the intravenous formulation to the subcutaneous formulation, non-inferiority in ORR was confirmed (30% vs. 33%), administration time was reduced (4-5 hours → 5 minutes), IRR side effects decreased (13% vs. 66%), mPFS improved (6.1 months vs. 4.3 months), a trend toward OS improvement was observed (HR 0.62), and VTE (venous thromboembolism) side effects improved (9% vs. 14%).”
The researcher added, “Having presented superior clinical results compared to the existing intravenous formulation, it was selected as the 2024 Best of ASCO. Based on the PALOMA-3 clinical results, Janssen has completed submission of the approval application for Lazertinib + Amivantamab SC to the European EMA, and plans to submit approval applications to other countries including the United States in the future.”
He also stated, “At ASCO, Janssen presented the results of the Phase 1 CHRYSALIS2 Cohort C clinical trial of Lazertinib + Amivantamab IV in patients with uncommon EGFR mutations (S768I, L861Q, G719X, etc.) positive non-small cell lung cancer. The clinical results showed an ORR of 51% and mPFS of 11.1 months for all patients, and for patients without prior treatment history, an ORR of 55% and mPFS of 19.5 months were recorded.”
He analyzed, “Although direct comparison is difficult, compared to the existing treatment Geotrip, which recorded an mPFS of 8.2 to 14.7 months in patients without prior treatment history, a somewhat longer mPFS of 19.5 months was achieved. Treatment efficacy was confirmed in uncommon mutation-positive non-small cell lung cancer, and additionally, in six patients who had previously been treated with Geotrip, an ORR of 45% and mPFS of 5.7 months were recorded, confirming its effectiveness as a second-line treatment, thus indicating the potential for future indication expansion.”
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