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Also known as M7824
Bintrafusp alfa · 5 trials · 11 indications
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment.
Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
To evaluate the objective tumor response (ORR) to bintrafusp alfa in previously treated R/M NPC patients per response evaluation criteria of solid tumor (RECIST) version 1.1
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
DLT was defined as Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (\>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting \>= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for \>= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (\<) 1,000/mm3 with a temperature of \> 38.3 degree Celsius (°C); grade 4 is defined as ANC \< 1,000/mm3 with a temperature of \> 38.3°C, with life-threatening consequences; Thrombocytopenia \< 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events \>= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (\> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included serious TEAEs and non-serious TEAEs.
| Arm | Type | Description |
|---|---|---|
| Bintrafusp alfa | EXPERIMENTAL | - |
| M7824 | EXPERIMENTAL | - |
| Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab | EXPERIMENTAL | - |
| Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel | EXPERIMENTAL | - |
| Cohort 2: M7824+Cisplatin+ Radiotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bintrafusp alfa | DRUG | Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal. |
| M7824 | DRUG | Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal. |
| Carboplatin | DRUG | Carboplatin was administered intravenously as per standard of care. |
| Paclitaxel | DRUG | Paclitaxel was administered intravenously as per standard of care. |
| Bevacizumab | DRUG | Bevacizumab was administrated as indicated for standard of care. |
| Cisplatin | DRUG | Cisplatin was administered intravenously as per standard of care. |
| Radiotherapy | RADIATION | Participants received radiotherapy as per standard of care. |
Inclusion Criteria: * Participants who are currently enrolled in an eligible bintrafusp alfa parent study where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed or after discontinuation of study before primary/main analys...
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Bintrafusp alfa is an investigational oncology therapy developed by Merck KGaA (ticker MKGAF). It is being studied in lung cancer, nasopharyngeal carcinoma, and uterine cervical neoplasms. It is a Phase 3 clinical development candidate and has not been approved by the FDA. It is designed as a bifunctional binding agent directed at CD274 and the TGFB1, TGFB2, and TGFB3 targets.
Bintrafusp alfa targets CD274, also known as PD-L1, together with the transforming growth factor beta ligands TGFB1, TGFB2, and TGFB3. It is classified as a binding agent, meaning it is designed to bind these targets simultaneously. This dual-target approach distinguishes it from therapies that address only one of these pathways.
Bintrafusp alfa is developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA is the sponsor behind the clinical program evaluating the drug across several tumor types, including lung cancer, nasopharyngeal carcinoma, and cervical cancer. The company holds the asset as part of its oncology pipeline.
Bintrafusp alfa is in Phase 3 clinical development. It is an investigational agent and is not FDA approved. The Phase 3 activity is represented by a program rollover study, while additional studies in nasopharyngeal carcinoma and cervical cancer were conducted at Phase 2. All listed trials have completed.
Bintrafusp alfa has been evaluated in three completed trials. NCT05061823 was a Phase 3 program rollover study in lung cancer and other cancers. NCT04396886 was a Phase 2 study in previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. NCT04246489 was a Phase 2 monotherapy study in platinum-experienced cervical cancer.
Bintrafusp alfa was studied as a monotherapy in platinum-experienced cervical cancer in the Phase 2 NCT04246489 trial, which enrolled 146 female patients across multiple countries. The study has completed. Bintrafusp alfa remains investigational and is not approved for cervical cancer or any other indication.