Tislelizumab (1) – Tevimbra®

Squamous cell carcinoma of the oesophagus, after prior therapy

Characteristics

Start date 01.01.2025 – Marketing authorisation: 15.09.2023
Resolution 18.06.2025
INN Tislelizumab
Brand name Tevimbra®
Pharm. company Dossier: BeiGene Germany GmbH
New distributor: BeOne Medicines Germany GmbH
G-BA Procedure ID D-1125
ATC code L01FF09 PD-1/PDL-1 inhibitors (L01FF)
ICD-10 codes (AIS) C15.0, C15.1, C15.2, C15.3Malignant neoplasm of upper third of esophagus, C15.4Malignant neoplasm of middle third of esophagus, C15.5Malignant neoplasm of lower third of esophagus, C15.8Malignant neoplasm of overlapping sites of esophagus, C15.9Malignant neoplasm of esophagus, unspecified
Alpha-ID codes (AIS) I113992Squamous cell carcinoma of the esophagus, I134243Oesophageal carcinoma, overlapping several sub-areas, I25397Malignant neoplasm of the cervical esophagus, I25398Malignant neoplasm of the thoracic esophagus, I25399Malignant neoplasm of the abdominal esophagus, I29934Malignant neoplasm of the upper third of the esophagus, I29935Malignant neoplasm of the middle third of the esophagus, I29936Malignant neoplasm of the lower third of the esophagus
Therapeutic area Oncological diseases Squamous cell carcinoma
Reason for procedure Initial assessment
Specialty Bundling ACT change

Therapeutic indication of the resolution

Tevimbra as monotherapy is used for the treatment of unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy in adult patients.
Subpopulation Indication Comparator
Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus after prior platinum-based chemotherapy Nivolumab

Studies and Results

No. of studies
(best subpopulation) 		1 (RATIONALE 302) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. ACT)
ACT change 27.02.2024 – Neue Leitlinien

  • Clinical trials
    • The pharmaceutical manufacturer submitted the results of the RATIONALE 302 randomised controlled trial for the benefit assessment of tislelizumab for the treatment of adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy.
    • The RATIONALE 302 study is an open-label Phase III trial comparing tislelizumab with treatment at the clinician’s discretion, selected from docetaxel, paclitaxel and irinotecan.

Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy

  • Additional benefit is not proven for tislelizumab in the treatment of adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy.

Courtesy translation only, please refer to the German original.

Associated procedures

Tislelizumab (9) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy 5,090–5,780 100% additional benefit not proven
Tislelizumab (8) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line treatment, in combination with gemcitabine and cisplatin 70–120 100% additional benefit not proven
Tislelizumab (7) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Small cell lung cancer, first-line treatment, in combination with etoposide and platinum-based chemotherapy 3,820–8,124 100% additional benefit not proven
Tislelizumab (6) Tevimbra® BeiGene Germany GmbH Oncological diseases Adenocarcinoma of the stomach or gastro-oesophageal junction, PD-L1 expression ≥ 5, HER2-, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy 1,941–3,067 100% additional benefit not proven
Tislelizumab (4) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, after prior therapy 690–1,620 100% additional benefit not proven
Tislelizumab (2) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, non-squamous, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-containing chemotherapy 3,460–4,600 100% additional benefit not proven
Tislelizumab (3) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel 7,780–11,040 100% additional benefit not proven
Tislelizumab (5) Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression TAP score ≥ 5%, first-line, combination with platinum-based chemotherapy 1,530–2,050 100% additional benefit not proven
Tislelizumab (1) Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, after prior therapy 330–540 100% additional benefit not proven


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