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GME751 · 2 trials · 2 indications
Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
The PK similarity (AUCtau\_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
| Arm | Type | Description |
|---|---|---|
| GME751 + pemetrexed + carboplatin or cisplatin | EXPERIMENTAL | Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| Keytruda-EU + pemetrexed + carboplatin or cisplatin | ACTIVE_COMPARATOR | Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| GME751 | EXPERIMENTAL | Subjects will receive GME751 via intravenous (IV) infusion. |
| Keytruda - EU | ACTIVE_COMPARATOR | Subjects will receive Keytruda-EU via intravenous (IV) infusion. |
| Keytruda - US | ACTIVE_COMPARATOR | Subjects will receive Keytruda-US via intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| GME751 | DRUG | Drug: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
| Keytruda-EU | DRUG | Drug: Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
| Keytruda - EU | DRUG | 400 mg Q6W, i.v. infusion, over 24 weeks period |
| Keytruda - US | DRUG | 400 mg Q6W, i.v. infusion, over 24 weeks period |
Inclusion Criteria: * At least 18 years of age * Untreated metastatic NSCLC * Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements * Measurable disease according to RECIST 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status score...
GME751 is an investigational biosimilar to pembrolizumab (Keytruda) being developed for oncology indications. It has been studied in participants with Stage II and III melanoma and in adults with untreated metastatic non-squamous non-small cell lung cancer (NSCLC). It is currently in clinical development and is not approved.
GME751 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials to compare GME751 with Keytruda in melanoma and metastatic NSCLC.
GME751 is in Phase 1 clinical development. One completed Phase 1 trial compared GME751 with Keytruda in Stage II and III melanoma, and a separate completed Phase 3 trial studied it in metastatic NSCLC. The drug remains investigational and is not FDA approved.
GME751 has been studied in two completed trials. NCT06153238 is a Phase 1 pharmacokinetic study comparing GME751 with US-licensed and EU-authorized Keytruda in Stage II and III melanoma. NCT06159790 is a Phase 3 study comparing GME751 with EU-authorized Keytruda in untreated metastatic non-squamous NSCLC.
GME751 is a proposed biosimilar to pembrolizumab, the active ingredient in Keytruda. It is designed to be highly similar to the reference product, but it is not the same as the originator biologic. Clinical trials are comparing GME751 with Keytruda to assess similarity in efficacy, safety, and immunogenicity.
GME751 is a proposed biosimilar to pembrolizumab, which targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is intended to block the interaction with its ligands, potentially enhancing the immune system's ability to fight cancer cells.