Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bintrafusp alfa · 3 trials · 7 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
| Arm | Type | Description |
|---|---|---|
| Bintrafusp alfa | 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. |
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 being studied for use in lung cancer, nasopharyngeal carcinoma, and uterine cervical neoplasms. It is a small molecule in Phase 2 clinical development. It has been evaluated in patients with platinum-experienced cervical cancer and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Bintrafusp Alfa is being developed by Merck KGaA, a biopharmaceutical company. The company's stock is traded under the ticker MKGAF. The drug is currently in Phase 2 clinical trials for oncology indications.
Bintrafusp Alfa is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for cervical cancer and nasopharyngeal carcinoma, with a Phase 3 rollover study also completed.
Bintrafusp Alfa has been studied in several clinical trials. NCT04246489 was a Phase 2 trial in platinum-experienced cervical cancer with 146 participants. NCT04396886 was a Phase 2 trial in previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma with 38 participants. NCT05061823 was a Phase 3 rollover study in lung cancer with 22 participants.
Yes, Bintrafusp Alfa has been studied in uterine cervical neoplasms. A Phase 2 clinical trial (NCT04246489) evaluated Bintrafusp Alfa monotherapy in platinum-experienced cervical cancer patients. The trial enrolled 146 female participants aged 18 years and older across multiple countries.