PF-08634404 / 3SBio, Pfizer - LARVOL DELTA

C6461001: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrialsregister.eu) - P2/3 | N=203 | Not yet recruiting | Sponsor: Pfizer Inc.

New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

C6461003: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer (clinicaltrialsregister.eu) - P2/3 | N=92 | Not yet recruiting | Sponsor: Pfizer Inc.

New P2/3 trial • Colorectal Cancer • Oncology • Solid Tumor

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1

A phase II/III trial of a PD-1/VEGF bispecific antibody (PF-08634404) in combination with chemotherapy in first-line for extensive-stage small cell lung cancer (Symbiotic-Lung-04) (ELCC 2026) - P2/3 | "Approximately 40 patients will receive PF-08634404 plus carboplatin and etoposide for 4 cycles followed by PF-08634404 monotherapy. The primary endpoint is OS. Secondary endpoints include PFS, confirmed ORR, and DOR by blinded independent central review and safety."

Bispecific • Clinical • Combination therapy • P2/3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-1

A phase Ib/II trial of a PD-1/VEGF bispecific antibody (PF-08634404) in combination with anticancer agents in first-line (1L) for advanced solid tumors (Symbiotic-Lung-20) (ELCC 2026) - P1/2 | "In parts A and B, PF-08634404 is combined with different vedotin-based antibody-drug conjugates (ADCs; sigvotatug vedotin and PDL1V) in patients (pts) with pathologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC who have not received prior systemic therapy in 1L. Key secondary endpoints include DCR, DOR, and PFS all by investigator, and OS. Enrollment has begun."

Bispecific • Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

A phase III trial of a PD-1/VEGF bispecific antibody (PF-08634404) vs pembrolizumab in combination with platinum-based chemotherapy in first-line for locally advanced or metastatic non-small cell lung cancer (Symbiotic-Lung-01) (ELCC 2026) - P3 | "In part 1, ≈640 pts with squamous NSCLC will be randomized 1:1 to receive either PF-08634404 or pembrolizumab intravenously plus carboplatin and investigator's choice of paclitaxel or nab-paclitaxel for 4 cycles followed by maintenance therapy with PF-08634404 or pembrolizumab for up to 35 cycles. In part 2, ≈770 pts with nonsquamous NSCLC will be randomized 1:1 to receive either PF-08634404 or pembrolizumab plus carboplatin and pemetrexed for 4 cycles followed by maintenance therapy with PF-08634404 or pembrolizumab plus pemetrexed for up to 35 cycles, after which pemetrexed may continue...All endpoints will be assessed in each part. Enrollment has begun."

Bispecific • Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Dose optimization and exposure-response (ER) analysis for PF-08634404, an investigational anti-PD-1 and anti-VEGF bispecific antibody (AACR 2026) - "Abstract is embargoed at this time."

Bispecific • Late-breaking abstract • Oncology

Characterization and functional evaluation of PF-08634404 (SSGJ-707) a tetravalent PD-1 x VEGF bispecific for the treatment of cancer (AACR 2026) - "Consistent with this class of bispecific molecules, PF-08634400 multimerizes in the presence of dimeric VEGF-A, increasing the avidity for PD-1 (>100-fold), driving rapid internalization of PD-1 on T cells, and improving the functional inhibition of PD-1 (>10-fold). Collectively, these data characterize core features of the bispecific mechanism and support the ongoing clinical investigation of PF-08634404 proof of concept and pivotal trials in multiple disease settings/tumor types."

Bispecific • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Pfizer

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR

C6461008: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

C6461020: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers (clinicaltrials.gov) - P1/2 | N=162 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=132 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1/2 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=1410 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer (clinicaltrials.gov) - P2/3 | N=840 | Not yet recruiting | Sponsor: Pfizer

New P2/3 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=550 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

C6461013: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. (clinicaltrials.gov) - P1/2 | N=138 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1/2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=550 | Not yet recruiting | Sponsor: Pfizer

New P2/3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=1500 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study (SITC 2025) - P2 | "In Part 1, patients with nonsquamous NSCLC received SSGJ-707 at 5/10/20 mg/kg or tislelizumab with carboplatin+pemetrexed...Based on the selected dose from cohort A, Part 2 cohort B evaluated SSGJ-707 10 mg/kg or tislelizumab with carboplatin + paclitaxel or SSGJ-707 10 mg/kg + carboplatin + nab-paclitaxel in squamous NSCLC.Results At the data cutoff of July 4, 2025, 119 patients with nonsquamous NSCLC and 125 with squamous NSCLC were enrolled in Parts 1 and 2, respectively...ORRs with SSGJ-707 exceeded that of tislelizumab + chemotherapy. These results support further evaluation of SSGJ-707 10 mg/kg Q3W combined with chemotherapy in a phase 3 study in first-line NSCLC regardless of PD-L1 expression.Abstract 1328 Table 1View inline•Open as popupEfficacy and safetyAbstract 1328 Figure 1Request permissionsWaterfall plots for SSGJ-707 + chemotherapy in Part 1, Part 2 cohort A, and Part 2 cohort B"

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study (SITC 2025) - P2 | "In Part 1, patients with nonsquamous NSCLC received SSGJ-707 at 5/10/20 mg/kg or tislelizumab with carboplatin+pemetrexed...Based on the selected dose from cohort A, Part 2 cohort B evaluated SSGJ-707 10 mg/kg or tislelizumab with carboplatin + paclitaxel or SSGJ-707 10 mg/kg + carboplatin + nab-paclitaxel in squamous NSCLC.Results At the data cutoff of July 4, 2025, 119 patients with nonsquamous NSCLC and 125 with squamous NSCLC were enrolled in Parts 1 and 2, respectively...ORRs with SSGJ-707 exceeded that of tislelizumab + chemotherapy. These results support further evaluation of SSGJ-707 10 mg/kg Q3W combined with chemotherapy in a phase 3 study in first-line NSCLC regardless of PD-L1 expression.Abstract 1328 Table 1View inline•Open as popupEfficacy and safetyAbstract 1328 Figure 1Request permissionsWaterfall plots for SSGJ-707 + chemotherapy in Part 1, Part 2 cohort A, and Part 2 cohort B"

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

A phase II trial to evaluate the safety and efficacy of SSGJ-707: A bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in patients with metastatic CRC (ESMO 2025) - P2 | "Conclusions SSGJ-707 in combination with XELOX/mFOLFOX6 demonstrated promising efficacy results in 1L mCRC with manageable safety profile. The study of SSGJ-707 monotherapy in ≥3L mCRC and in combination with chemotherapy for the whole pMMR/MSS 1L mCRC pts is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers (clinicaltrials.gov) - P1/2 | N=162 | Not yet recruiting | Sponsor: Pfizer

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pfizer built its confidence in its phase 3 approach for PF-08634404 based on results from a phase 2 trial conducted by 3SBio in China. (FierceBiotech) - "In the study, treatment with the bispecific at 10 mg/kg and chemo yielded an overall response rate (ORR) of 58.6% in patients with nonsquamous NSCLC. Further, the ORR was 69.2% among those with squamous disease who were treated with the bispecific when the chemo partner was nab-paclitaxel and 37.5% when paclitaxel was the combo partner...The ORR for the squamous population was calculated after a 'considerably shorter' follow-up period, Legos noted. The results were presented at the Society for Immunotherapy of Cancer 2025 annual meeting during this past weekend."

P2 data • Lung Non-Squamous Non-Small Cell Cancer