Loqtorzi

Oncology· 763 cited findings· 1 source document

Company: Topalliance Biosciences

What the regulatory reviews say

Loqtorzi (toripalimab) is a monoclonal antibody with the ATC Code L01FF13, approved for specific indications. It is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Additionally, Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

Key efficacy findings include a BIRC-determined Progression-Free Survival (PFS) of 21.4 months (95% CI: 11.73, not estimable) and 8.2 months (95% CI: 7.03, 9.79). The median PFS for the placebo + paclitaxel/cisplatin arm was 5.5 months. Overall Survival (OS) was not estimable (NE) (95% confidence interval: 38.7, NE) and 33.7 months (95% confidence interval: 27.0, 44.2), with an OS p-value of 0.0083. The BIRC-determined Objective Response Rate (ORR) was 77.4% (95% confidence interval: 69.7, 83.9) and 66.4% (95% confidence interval: 58.1, 74.1). The BIRC-determined Duration of Response (DOR) Median was 10.0 months and 5.7 months.

Safety assessments identified a No Observed Adverse Effect Level (NOAEL) of 100 mg/kg. Mean Cmax values were 3.52 mg/mL for males and 3.11 mg/mL for females, with mean AUCinf values of 854 mg*h/mL and 760 mg*h/mL, respectively. Exposure margins for Cmax and AUC were 49.1x and 20x, respectively, with safety margins (AUC0-t) of 20.12-fold and 49.31-fold. The application submission date was 13 November 2022, with a CHMP Positive Opinion Date of 25 July 2024.

Key figures — cited to the source page

BIRC-determined PFS	21.4 months	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.138
BIRC-determined PFS (95% CI)	11.73, not estimable (NE)	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.139
OS p-value	0.0083	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.139
BIRC-determined ORR	77.4%	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.139
BIRC-determined DOR Median	10.0 months	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.139
NOAEL	100 mg/kg	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.34
Approved Indication	Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.2
CHMP Positive Opinion Date	25 July 2024	Topalliance Biosciences — Loqtorzi EMA EPAR public assessmen, p.10

Source documents

Topalliance Biosciences — Loqtorzi EMA EPAR public assessment report (EMEA/H/C/006120, 2024) (2024)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.