[Click e-Stock] "Selbion Begins Combination Clinical Trials with Keytruda"

Daishin Securities stated on June 27 that Selbion's initiation of combination clinical trials with Keytruda has laid the groundwork for global technology transfer.

Lee Heeyoung, a researcher at Daishin Securities, explained, "In February, Selbion signed a clinical trial collaboration and supply agreement with Merck for the combination administration of Keytruda. On June 23, the company received approval for the clinical trial plan (IND) for a domestic phase 1 trial of the combination therapy. The clinical trials are expected to begin in the second half of this year."

He continued, "Merck failed in the phase 3 clinical trial (KEYNOTE-921) of docetaxel plus Keytruda for patients with mCRPC. Lu-pocuvotide, Selbion's radiopharmaceutical therapy under development, is considered a strong partner to meet the need for expanded combination indications for Keytruda."

He added, "We expect improvements in efficacy and safety compared to the existing Pluvicto combination. Depending on the clinical results, global joint development and technology transfer negotiations may become possible."

The researcher further analyzed, "After the topline results are announced in August this year, the clinical study report (CSR) will be received in the fourth quarter. The company is expected to apply for conditional approval."

He emphasized, "Selection for the Global Innovative Pharmaceutical Fast Track (GIFT) system will enable expedited review, and domestic launch is anticipated in the first half of next year."