Supplementary Table S2 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Table S2. Study representativeness.</p

Supplementary Table S3 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Table S3. Serious treatment-related adverse events. Bleeding events: a One patient had two consecutive hematuria events, and another patient also had two events, the first episode related to bevacizumab, the second episode due to bintrafusp alfa. All hematuria events resolved within 4-6 weeks. b One patient treated with blood transfusion and vaginal tamponade, resolved within 2 days; other patient required blood transfusion and event resolved within 3 weeks. c Patient presented with bloody diarrhea and stomach discomfort, assessed as being caused by late radiation therapy and a rectal ulcer due to bevacizumab use; resolved with fasting and fluid replacement within 2 weeks. d Mucosal bleeding assessed as being caused by bintrafusp alfa and bevacizumab use; resolved with blood transfusion. e One event resolved with tumor compression by gauze and blood transfusion within a few days. f Bleeding in the duodenum resolved with standard gastrointestinal medication and fluid replacement within one week. g Rectal bleeding along with urinary tract infection; patient treated in emergency room with antibiotics and discontinuation of heparin for prior thrombosis, symptoms resolved within 2 weeks. AE, adverse event; SARS-CoV-2, severe acute respiratory syndrome-coronavirus-2.</p

Supplementary Table S4 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Table S4. Pharmacokinetic exposure summary. AUC, area under the curve; Ceoi, concentration at end of infusion; Ctrough, concentration at the end of the dosing interval; CV, coefficient of variation; NA, not applicable; popPK, population pharmacokinetic; SD, standard deviation.</p

Supplementary Table S1 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Table S1. Median duration of therapy. IQR, interquartile range; NA, not applicable.</p

Supplementary Methods S1 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Supplementary Methods</p

Supplementary Figure S1 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Figure S1. Change from baseline in sum of diameters of all target lesions per RECIST v1.1 for (A) Cohort 1A and (B) Cohort 1B. CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.</p

Supplementary Figure S3 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Figure S3. Patient-level concentration profile of bintrafusp alfa at Day 1 postdose.</p

Supplementary Figure S2 from Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer

Figure S2. Change from baseline in sum of diameters of all target lesions per RECIST v1.1 for Cohort 2. CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.</p