Daiichi Sankyo (4568) Discontinuation of Trodelvy 1L NSCLC PD-L1 ≥50% trial might seem to have negative implications for TL-08

Research evidence excerpt

Daiichi Sankyo (4568) Discontinuation of Trodelvy 1L NSCLC PD-L1 ≥50% trial might seem to have negative implications for TL-08

J P M O R G A N Asia Pacific Equity Research

09 June 2026

Daiichi Sankyo (4568) Neutral

4568.T, 4568 JP

Discontinuation of Trodelvy 1L NSCLC PD-L1 ≥50% Price (08 Jun 26):¥2,529

trial might seem to have negative implications for TL-08 Price Target (Dec-26):¥2,750

On June 8 (local time), Merck & Co. and Gilead Sciences announced the Japan Equity Research

discontinuation of the KEYNOTE-D46/EVOKE-03 trial (Trodelvy [sacituzumab

Biotechnology & Pharmaceuticals/

govitecan] in combination with Keytruda versus Keytruda monotherapy, AGA Medical Technologies & Services

negative, approximately 620 patients) in 1L metastatic NSCLC patients whose AC Seiji Wakao, Ph.D.

tumors expressed PD-L1 TPS ≥50% due to a low likelihood of meeting pre-

(81-3) 6736-8612

specified efficacy criteria. The decision was based on the recommendations of an seiji.wakao@jpmorgan.com

independent data monitoring committee. The committee concluded that although Yugo R. Kamimura, Ph.D.

the Trodelvy-Keytruda combination produced a “numerical improvement” in (81-3) 6736-8635

progression-free survival (PFS; dual primary endpoint), it failed to achieve yugo.kamimura@jpmorgan.com

statistical significance, and that the probability of achieving a significant overall Naoko Saito

survival benefit (OS; dual primary endpoint) at the final analysis was “unlikely.” (81-3) 6736-8693

No new safety signals were identified. naoko.saito@jpmorgan.com

JPMorgan Securities Japan Co., Ltd.

The results of this study reaffirm that Keytruda monotherapy already has good

treatment results in patients with high PD-L1 expression, and it is difficult to show

additional benefits from other drugs.