SSGJ-707

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy. In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival (OS) compared to docetaxel. The safety profile of sigvotatug vedotin was manageable and consistent with prior studies. Encouragingly, in patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and progression-free survival (PFS) for sigvotatug vedotin over docetaxel. In the exploratory analysis, no clear IB6 expression-response relationship was observed. Detailed results from SigVie-002 will be submitted for presentation at a future medical congress. “Patients with previously treated advanced NSCLC are a historically difficult-to-treat population, and there is clearly more work to be done to improve the outcomes for this population,” said Jeff Legos, Chief Oncology Officer, Pfizer. “Although the overall study results did not demonstrate superiority over docetaxel, it is encouraging that second-line patients treated with sigvotatug vedotin achieved strong efficacy outcomes compared to an established standard of care, alongside a manageable safety profile. This observed clinical benefit, along with our Phase 1 combination data in the first-line setting, reinforces our confidence in the potential of the sigvotatug vedotin program, including an ongoing Phase 3 trial in combination with pembrolizumab in first-line advanced NSCLC.” “It is important not to underestimate the activity of docetaxel as a comparator in this setting. Patients enrolled in this trial were heavily pre-treated, with most having previously received both platinum-based chemotherapy and immunotherapy, yet docetaxel continues to provide meaningful clinical benefit. Although the study did not meet its overall survival endpoint, in second-line patients the data suggest a clinically meaningful survival benefit for sigvotatug vedotin over docetaxel, supporting continued scientific evaluation of sigvotatug vedotin in earlier lines in combination with immunotherapy,” said Solange Peters, M.D., PhD, Chair of Medical Oncology & Thoracic Cancers Clinic, Lausanne University Hospital, Switzerland. “The ability of sigvotatug vedotin to induce immunogenic cell death provides a strong rationale for combination approaches with immunotherapy, particularly in earlier treatment settings where immune competence is better preserved. In this context, the promising phase 1 efficacy signals observed in treatment-naïve patients with high PD-L1 expression warrant further evaluation and may represent a more effective clinical application of this strategy.” In NSCLC, IB6 is expressed on approximately 90% of tumors. IB6 is associated with poor prognosis. Sigvotatug vedotin is a novel ADC designed for high target selectivity of IB6 and rapid internalization, which may help limit binding to other integrins more likely to be expressed in normal tissues and potentially reduce off-target toxicity. Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors, including: An ongoing Phase 3 study evaluating sigvotatug vedotin + pembrolizumab in 1L NSCLC with PD-L1 tumor proportion score (TPS) ≥50%; and Exploration of sigvotatug vedotin in novel combinations, including with PF’4404, the novel bispecific antibody targeting PD-1 and VEGF, in early-stage lung cancers and other IB6-expressing tumors. Since the acquisition of Seagen, Pfizer has continued to advance a broad ADC portfolio spanning marketed medicines and pipeline programs. Pfizer is progressing multiple differentiated ADC candidates, including fetrastobart vedotin, a PD-L1–directed ADC currently in Phase 3 in NSCLC, additional IB6-targeted ADCs with alternate payloads, and early-stage candidates exploring novel targets and payloads, including topoisomerase I (Topo1) inhibitors and novel auristatin-based payloads. This breadth reinforces the strength of Pfizer’s Oncology pipeline, including the potential for novel combinations with its investigational PD-1xVEGF bispecific antibody (PF-08634404), supporting the company’s goal of delivering 8 potential Oncology breakthroughs by 2030. About the SigVie-002 Trial SigVie-002 (NCT06012435) is an ongoing, open-label randomized, Phase 3, global study evaluating sigvotatug vedotin compared with docetaxel in adult participants with previously treated locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC). Patients were randomized to receive sigvotatug vedotin administered intravenously on Days 1 and 15 of each 28-day cycle or docetaxel administered intravenously on Day 1 of each 21-day cycle. The primary endpoint of this trial is overall survival (OS). The study enrolled 703 participants. Descriptive, secondary endpoints include progression-free survival (PFS), confirmed objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 as assessed by blinded independent central review (BICR). For more information, visit ClinicalTrials.gov and reference NCT06012435. 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 other immune-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, hematology-oncology, and thoracic cancers, which includes lung cancer. 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 over 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 at www.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 Facebook.com/Pfizer . Disclosure Notice The information contained in this release is as of June 22, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology, sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 directed antibody-drug conjugate, other oncology pipeline candidates and Pfizer’s ADC portfolio, including their potential benefits, the development program for sigvotatug vedotin and Pfizer’s oncology pipeline portfolio, the SigVie-002 results for sigvotatug vedotin and Pfizer’s goal of delivering 8 or more potential Oncology blockbuster medicines by 2030, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data, as well as uncertainties regarding the future of the sigvotatug vedotin program; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for sigvotatug vedotin or any other product candidates or combinations may be filed in particular jurisdictions for any potential indications; whether and when any such applications for sigvotatug vedotin or any other product candidates or combinations may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether sigvotatug vedotin or any such other product candidates or combinations will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of sigvotatug vedotin or any other product candidates or combinations; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its reports subsequent on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Media Contact: +1 (212) 733-1226 PfizerMediaRelations@Pfizer.com(link sends email) Investor Contact: +1 (212) 733-4848 IR@Pfizer.com(link sends email) Source: Pfizer Inc.

Facing increasingly high expectations as the front-runner in the PD-1/VEGF bispecific race, Summit Therapeutics and Akeso's ivonescimab looks to have risen to the occasion. The experimental treatment notched a key clinical win in a Phase III Chinese study that investors and physicians alike hope will bolster the chances of success for a separate late-stage global trial in patients with non–small-cell lung cancer (NSCLC).During Sunday's plenary session at the American Society of Clinical Oncology (ASCO) meeting, investigators on the HARMONi-6 study presented hotly anticipated overall survival (OS) results, which met statistical significance (see – Spotlight On: Lung cancer bispecifics poised to take centre stage at ASCO this year and Spotlight On: Five things to watch at ASCO).HARMONi-6 enrolled 532 patients with advanced squamous NSCLC to receive either ivonescimab or BeOne Medicines' PD-1 inhibitor Tevimbra (tislelizumab), both in combination with chemotherapy. At a media briefing ahead of the presentation, ASCO's lung cancer expert, David Spigel, called squamous NSCLC a disease with "largely unmet medical need," adding that "this group still often has a very poor prognosis, even with advanced therapies like chemotherapy and immunotherapy." Spigel is the chief scientific officer of the Sarah Cannon Research Institute in Tennessee.OS benefit of 4.2 monthsAs of the Feb. 27 data cut-off, patients taking ivonescimab achieved a median OS of 27.9 months versus 23.7 months for Tevimbra, translating to a 34% reduction in the risk of death (HR 0.66; p=0.0017) after a median follow-up of 21.4 months.Ahead of the ASCO readout, FirstWord spoke with Lyudmila Bazhenova, a medical oncologist and professor of medicine at University of California San Diego Moores Cancer Center, who said a six-month improvement in OS would be a "great" outcome for ivonescimab, though she added that she "would even be happy if we see an absolute benefit of four months" (see – KOL Views Q&A: Ivonescimab's HARMONi-3 update further tempers hopes for all-or-nothing prospects of PD-1/VEGF bispecifics).On the safety front, study investigators called ivonescimab's profile "comparable" to Tevimbra. About 69% of patients receiving the bispecific experienced a grade 3 or higher treatment-related adverse event (AE), with 5.3% discontinuing treatment, compared with rates of 58.9% and 4.5%, respectively, for the Tevimbra arm. The trial also looked at possibly VEGF-related any-grade AEs, which occurred more frequently in the experimental cohort than the comparator. Such AEs included proteinuria (42.5% vs 12.8%), haemorrhage (24.8% vs 12.1%), hypertension (14.7% vs 5.7%), arterial thromboembolism (1.5% vs 0%) and venous thromboembolism (0.8% vs 1.1%).Up next, a global stageThe findings provide important evidence that positive progression-free survival (PFS) data for PD-(L)1/VEGF inhibitors can translate to a meaningful OS benefit. At last year's European Society for Medical Oncology (ESMO) meeting, Summit and Akeso presented data showing that ivonescimab led to a median PFS of 11.1 months versus 6.9 months for Tevimbra — cutting the risk of disease progression or death by 40%.ASCO's positive OS readout could also be a much-needed confidence booster for Summit's global NSCLC study, HARMONi-3, after an update at the end of April seemed to shake investors. As part of its first-quarter earnings report, the drugmaker disclosed that a preplanned interim PFS analysis of the squamous cohort missed the bar for success, with a final PFS analysis to be conducted as planned in the second half of 2026.However, Spigel was cautious as to the applicability of the HARMONi-6 results — which he called "quite noteworthy" — to global patient populations. "It's hard to know how this [data] applies to a population of patients beyond [China]," he said. "Are there differences in ethnicity that affect how drugs like this work? We wait on other studies like the HARMONi-3 study, but these results are certainly very encouraging."While Summit — and physicians — wait for the HARMONi-3 data to inform a potential FDA approval for ivonescimab, competition within the PD-(L)1/VEGF class is heating up.BioNTech and Bristol Myers Squibb shared Phase II findings for their entrant, pumitamig, at ASCO, as did Pfizer for its own PD-1/VEGF bispecific, PF-08634404.In the ROSETTA Lung-02 trial, which enrolled both squamous and non-squamous NSCLC patients, pumitamig plus chemotherapy demonstrated a confirmed ORR of 52.5% in 40 evaluable patients. Pfizer's candidate, evaluated as a monotherapy in previously untreated patients with PD-L1–positive advanced NSCLC, showed a confirmed ORR of 67.6% in 34 evaluable patients (see – ASCO26: After ivonescimab stumble, rivals unveil their own bispecific data).And outside of the bispecific space, antibody-drug conjugates (ADC) are increasingly encroaching on their lung cancer territory. Merck & Co. and Kelun-Biotech posted Phase III data at ASCO for their ADC, sacituzumab tirumotecan (sac-TMT), which, given in combination with Keytruda (pembrolizumab), reduced the risk of disease progression or death by 65% versus the PD-1 inhibitor alone in patients with previously untreated PD-L1–positive metastatic NSCLC (see – Spotlight On: Merck & Co. and Kelun threaten to rain on ivonescimab's ASCO parade).