Tivunatamig

SHANGHAI , Oct. 28, 2026 /PRNewswire/ -- At the 2026 European Society for Medical Oncology (ESMO) Congress, 3SBio presented long-term follow-up results from a Chinese Phase II clinical study of SSGJ-707 combined with chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC). The steadily growing efficacy benefit not only showed a significant improvement in objective response rate (ORR) versus the data first disclosed at last year's SITC (Society for Immunotherapy of Cancer) Annual Meeting, but also delivered excellent median progression-free survival (mPFS) of 13.6 and 13.8 months in squamous and non-squamous NSCLC, respectively—adding strong clinical evidence for this China-developed , bispecific antibody that has been out-licensed to a global partner. Main Text The updated poster reports long-term follow-up data from the Phase II study of tivunatamig (PF-08634404/SSGJ-707) combined with chemotherapy as a first-line treatment for advanced NSCLC in China. A total of 261 patients were enrolled, including 122 with non-squamous (nsq) NSCLC and 139 with squamous (sq) NSCLC. 50% of patients were aged ≥65 ye ars, 8 0% had a history of smoking, and more than 40% had a PD-L1 tumor proportion score (TPS) < 1%. At the selected dose of 10 mg/kg Q3W, the confirmed objective response rate (cORR) for tivunatamig combined with carboplatin + paclitaxel in squamous NSCLC (sq-NSCLC) was 80.7% (vs. 67.7% in the control group), while the cORR for tivunatamig combined with carboplatin + pemetrexed in non-squamous NSCLC (nsq-NSCLC) was 77.5% (vs. 44.7% in the control group). Table 1. Best Overall Response Parameter Tivunatamig 10 mg/kg + Carboplatin + Pemetrexed (Part 1, nsq) Tislelizumab + Carboplatin + Pemetrexed (Part 1, nsq) Tivunatamig 10 mg/kg + Carboplatin + Paclitaxel (Part 2, sq) Tivunatamig 10 mg/kg + Carboplatin + Nab-paclitaxel (Part 2, sq) Tislelizumab + Carboplatin + Paclitaxel (Part 2, sq) Patients evaluable, n 40 38 57 13 31 Confirmed ORR, % 77.5 44.7 80.7 69.2 67.7 (95% CI) (61.5–89.2) (28.6–61.7) (68.1–90.0) (38.6–90.9) (48.6–83.3) Best Overall Response, n (%) CR 0 0 1 (1.8) 0 0 PR 31 (77.5) 17 (44.7) 45 (78.9) 9 (69.2) 21 (67.7) SD 8 (20.0) 16 (42.1) 10 (17.5) 4 (30.8) 9 (29.0) Unconfirmed PR 0 0 0 1 (7.7) 0 PD 1 (2.5) 4 (10.5) 1 (1.8) 0 1 (3.2) NE 0 1 (2.6) 0 0 0 The poster disclosed the median PFS data for tivunatamig combined with chemotherapy, with the data cutoff date updated to August 6, 2026. Median PFS was 13.6 months in squamous NSCLC versus 8.3 months in the control group, and 13.8 months in non-squamous NSCLC versus 9.7 months in the control group. Although no head-to-head comparison is available, the mPFS for SSGJ-707 is the longest reported to date among PD-1/VEGF bispecific antib odies. Furthe rmore, compared with the abstract data at the February cutoff, the extended follow-up shows that overall PFS has continued to improve, with tivunatamig demonstrating a positive signal of "longer follow-up, more robust efficacy signal." This pattern of sustained benefit with prolonged follow-up carries important positive implications: on one hand, it indicates that the high response rate is not a transient effect seen in short-term evaluation and that responses are durable; on the other hand, the treatment group's advantage has not narrowed over time but the bene fit has su stained. For a Phase II study, this is a key positive signal supporting subsequent confirmatory Phase III trials. Additionally, the ctDNA clearance analysis presented in the poster is another differentiating highlight of the study. Among 126 patients with detectable baseline ctDNA who completed paired sampling, 61.9% achieved ctDNA clearance at C3D1 (Cycle 3 Day 1, approximately 9 weeks). Updated follow-up data showed that median PFS in the ctDNA-clearance population reached 16.4 months, significantly longer than the 9.6 months in the non-clearance populati on. Unlike the macroscopic tumor lesion shrinkage observed on imaging, ctDNA clearance points to the microscopic level: the DNA burden from tumor cells in the blood has dropped below the limit of detection. ctDNA clearance is a molecular signal of rapid, deep tumor killing by the drug, and the significantly longer median PFS in the ctDNA-clearance population also suggests it could serve as an early predictive biomarker for treatment benefit. Looking across the PD-1/VEGF bispecific antibody landscape, the uniqueness of SSGJ-707 combined with chemotherapy lies in the early observation of ctDNA clearance and the outstanding mPFS advantage in this population; this early molecular deep response implies the potential for superior long-term survival. In terms of safety, the incidence of ≥ Grade 3 treatment-related adverse events (TRAEs) with tivunatamig combined with platinum-based chemotherapy was broadly comparable to the tislelizumab control group. Since the SITC data disclosure, no new Grade 5 TRAEs were reported in the tivunatamig arm. Overall, for the PD-1/VEGF bispecific antibody landscape, the value of this long-term data extends beyond the impressive ORR and PFS results. The combination of manageable safety and ctDNA conversion signals enables tivunatamig to establish a differentiated advantage among comparable competing products, pending further validation in Phase III studies. Addressing Unmet Clinical Needs in Lung Cancer, Aiming to Become an IO 2.0 backbone Therapy Lung cancer is one of the malignancies with the heaviest global disease burden. According to GLOBOCAN 2022 statistics, there are approximately 2.48 million new cases of lung cancer globally each year, with more than 1.06 million new cases in China—accounting for over 40% of the global total—and non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancers. The large patient population has made the first-line advanced NSCLC landscape a highly competitive arena for both Chinese and global pharmaceutical companies. For a long time, this field has faced three challenges: the efficacy of existing immunotherapy combinations is approaching a plateau, anti-angiogenic regimens are underused in the lung squamous carcinoma population, and multi-drug combination regimens are cumbersome to administer—all areas of continuous industry effort. As described in the mechanism section of the abstract, by enhancing the inhibition of VEGF and the synergistic binding with PD-1, the agent effectively activates immune responses in the tumor microenvironment, achieving efficacy improvement under a safety profile. The PD-1/VEGF bispecific antibody is a crucial component of the IO 2.0 paradigm. Latest Development Status of tivunatamig (PF-08634404/SSGJ-707) Tivunatamig (PF-08634404/SSGJ-707) was independently developed by 3SBio. In 2025, 3SBio granted Pfizer the global development and commercialization rights for SSGJ-707, with a total potential transaction value exceeding $6 billion. The $1.4 billion upfront payment and $100 million equity investment set a new record for the largest upfront payment in a single out-licensing transaction for a Chinese innovative drug. Consequently, SSGJ-707 continues to attract significant industry attention and is regarded as a highly promising candidate among next-generation tumor immunotherapies. Since Pfizer took over the program, multiple global pivotal Phase III studies and indication-exploring Phase I/II studies of tivunatamig (PF-08634404/SSGJ-707) are currently underway. According to information disclosed by the company at recent industry conferences, tivunatamig has registered 11 international clinical trials a nd is be ing evaluated at more than 1,500 medical institutions globally. These long-term follow-up data represent an important step in the global validation journey of China's innovative drugs. A series of milestones traces the growth trajectory of SSGJ-707: securing clinical value through regulatory milestones, opening global pathways through BD collaboration, continuously generating efficacy evidence from the clinical program, and advancing global validation with high-density investment from a multinational pharmaceutical company. The long-term follow-up data announced at this ESMO Congress is the latest link in this trajectory—with PFS standing at the forefront among comparable Phase II studies, leaving room for differentiation in subsequent confirmatory Phase III studies. As a landmark project for the out-licensing of Chinese innovative drugs, its subsequent Phase III data will not only determine the commercial success of this bispecific antibody itself, but will also provide an important reference point for the PD-1/VEGF bispecific antibody landscape and the global development of Chinese innovative drugs. View original content to download multimedia: SOURCE 3SBio Inc.

Data across 45 abstracts will highlight new evidence for established medicines, including PADCEV and TALZENNA, and promising late-stage pipeline candidates such as atirmociclib and tivunatamig (PF’4404) NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data from 45 company-sponsored, investigator-sponsored, and collaborative research abstracts at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026 in Madrid, Spain. The presentations include 11 oral presentations spanning Pfizer’s established medicines and late-stage pipeline across its disease areas of focus, including breast cancer, genitourinary cancers, and lung cancer. “At Pfizer Oncology, we're focused on improving outcomes for people living with cancer. That means continuing to raise the standard of care today while pursuing the breakthroughs that will shape the future of oncology. The data we're presenting at ESMO reflect that focus, strengthening the evidence behind medicines such as PADCEV and TALZENNA, while advancing promising investigational candidates including atirmociclib and tivunatamig. By building on our leadership in breast, genitourinary, and lung cancers, we're working to bring meaningful progress to patients today and for years to come.” - Jeff Legos, Chief Oncology Officer, Pfizer Key Highlights of Pfizer’s Presence at ESMO 2026 Guiding the Next Wave of Oncology Innovation Phase 2 randomized results from the FOURLIGHT-1 study of atirmociclib, a highly selective cyclin-dependent kinase (CDK) 4 inhibitor, plus fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior CDK 4/6 inhibitor-based treatment. These results further support atirmociclib as a potential first-in-class cell cycle inhibitor backbone for HR+, HER2- MBC and Pfizer’s development strategy in earlier lines of therapy. A Phase 3 study in frontline MBC is ongoing and an additional Phase 3 study in early breast cancer is planned to evaluate atirmociclib in combination with giredestrant, an investigational oral selective oestrogen receptor degrader under development by Roche. (Presentation #1842O) Late-breaking overall survival (OS) and progression-free survival (PFS) results from the Phase 3 SigVie-002 study evaluating sigvotatug vedotin (SV), an investigational integrin β6 (IB6)-directed antibody-drug conjugate (ADC), as monotherapy in previously treated non-squamous non-small cell lung cancer (NSCLC). The findings will provide additional insight into previously announced topline results and inform the continued development of SV in earlier treatment settings, including an ongoing Phase 3 trial evaluating SV in combination with pembrolizumab in first-line advanced NSCLC and additional novel combinations under evaluation. (Presentation #LBA68) Updated Phase 2 data for tivunatamig (PF-08634404, PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in first-line PD-L1-expressing NSCLC. Tivunatamig is being developed as a potential best-in-class backbone therapy designed to combine two validated and complementary pathways in a single agent across tumor types, including ongoing pivotal studies in first-line NSCLC, first-line metastatic colorectal cancer, and advanced/recurrent endometrial cancer. Additional Phase 3 combination studies are planned, including with PADCEV ®(enfortumab vedotin-ejfv) in metastatic urothelial cancer. (Presentation #2660P) Expanding Evidence Across the Portfolio Updated exploratory analyses from the Phase 3 EV-302 trial evaluating outcomes with PADCEV plus pembrolizumab in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including among older patients, patients with comorbidities, and subgroups defined by disease-related characteristics. The findings further strengthen confidence in the regimen as a first-line foundation of care in la/mUC across clinically relevant populations. (Presentations #4760P and #4761P) Results from STARBOARD, a non-registrational Phase 3 trial evaluating an investigational triplet combination regimen of BRAFTOVI ®(encorafenib) and MEKTOVI ®(binimetinib) with pembrolizumab (KEYTRUDA ®) in first-line BRAF V600-mutant advanced melanoma. These findings contribute important evidence to an evolving treatment landscape. (Presentation #2071O) Deepening Understanding of Treatment Outcomes and Patient Experience Patient-reported outcomes and a safety analysis from the Phase 3 TALAPRO-3 study further supporting TALZENNA ®(talazoparib) plus XTANDI ® (enzalutamide) as a potential treatment option for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC; also known as metastatic APMN/S prostate cancer). A supplemental New Drug Application (sNDA) for TALZENNA plus XTANDI in mAPMN/S is currently under Priority Review by the U.S. Food and Drug Administration (FDA). (Presentations #2222RO and #2231P) An ad-hoc analysis from the Phase 3 EV-303 trial (also known as KEYNOTE-905) and circulating tumor DNA (ctDNA) and health-related quality of life analyses from the Phase 3 EV-304 (KEYNOTE-B15) trial. These analyses provide important biological and patient-centered context to previously reported survival data and further support perioperative PADCEV plus pembrolizumab as a new potential standard of care in muscle-invasive bladder cancer (MIBC). (Presentations #4733O, #4734O and #4738RO) ESMO Presence Reinforces Pfizer Oncology's Strategy to Advance Standards of Care and Deliver Next-Generation Breakthroughs As cancer remains the second-leading cause of death worldwide, Pfizer is focused on generating the evidence needed to bring treatment breakthroughs to as many patients as possible. Our data at ESMO reflect that strategy, concentrating innovation in disease areas with the greatest opportunity to impact patients globally. Highlights include emerging data from late-stage investigational programs advancing next-generation treatments, new analyses supporting established medicines as standards of care, and insights that deepen understanding of patient experience to better inform clinical decisions. Detailed Presentation Information Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (aPLS) for company-sponsored research being presented at ESMO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer and MIBC regardless of cisplatin eligibility. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI® (encorafenib) and full Prescribing Information for MEKTOVI® (binimetinib). Please see full Prescribing Information for PADCEV® (enfortumab vedotin-ejfv). Please see full Prescribing Information for TALZENNA® (talazoparib). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including immuno-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and lung cancers. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atwww.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at www.facebook.com/Pfizer/. Disclosure notice The information contained in this release is as of September 28, 2026. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. 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