GLOBAL RESEARCH ARCHIVE
1Q26 Reports: Substantial Value Ahead w/ JEMPERLI and Imsidolimab Royalties
Research evidence excerpt
1Q26 Reports: Substantial Value Ahead w/ JEMPERLI and Imsidolimab Royalties
ov) — Recruiting
• JEMPERLI up-to 24-month Ph2 (NCT05526989) in n=25 patients with penile carcinoma
with primary endpoint of ORR has primary completion listed as November, 2026 (per
clinicaltrials.gov) — Recruiting
• JEMPERLI 18-month Ph2 AZUR-1 (NCT05723562) in n=154 untreated Stage II/III dMMR/
MSI-H locally advanced rectal cancer patients with primary endpoint number of participants
with sustained complete clinical response for 12 months (cCR12) as assessed by an
independent central review at 18-months has primary endpoint listed as November 2, 2026
(per clinicaltrials.gov) with topline expected 2H26 (FDA Commissioner's National Priority
Voucher allows for a ~1-2-month sBLA review timeline for potential US approval) – Active,
not recruiting (status changed on August 4, 2025)
• JEMPERLI capecitabline + oxaliplatin (CAPEOX; chemotherapy) vs CAPEOX in the up-to
~18-week (up-to ~105-week) Ph2 AZUR-4 (NCT06567782) in n=120 untreated T4N0 or stage
II repair proficient (MMRp)/Microsatellite Stable (MSS) colon cancer patients with primary
endpoints major pathological response (mPR) rate at up-to ~18-weeks and safety at up-to
~105-weeks has primary completion listed as November 23, 2026 (per clinicaltrials.gov) with
potential data around ~4Q26 – Recruiting
• JEMPERLI up-to 48-month Ph2 DOVE (NCT06023862) in n=198 patients with gynecological
clear cell carcinoma with primary endpoint of progression free survival has primary completion
listed as August 31, 2027 (per clinicaltrials.gov) — Recruiting
• JEMPERLI has regulatory submission/decision in the US, EU, and Japan for rectal cancer
guided for 2027
• JEMPERLI up-to ~5-year Ph3 AZUR-2 (NCT05855200) in n=892 untreated T4N0 or stage
AnaptysBio, Inc.
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