On March 27, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen, Denmark. Three posters featuring updated ivonescimab data will be displayed on Friday, March 27 from 1:00 to 2:00 pm Central European Time. Data for HARMONi was generated and analyzed by Summit and for HARMONi-2 by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK).

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The first poster, "Intracranial Efficacy of Ivonescimab Plus Chemotherapy in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)-Resistant, EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) in the HARMONi Study" includes outcome data from patients with and without asymptomatic brain metastases at baseline enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI. Ivonescimab plus chemotherapy demonstrated an improvement in intracranial progression free survival (PFS) in patients with baseline brain metastases of 10.1 months compared to 6.5 months for chemotherapy (HR 0.53 (0.33-0.84); nominal p=0.0068). In patients who did not have baseline CNS metastases, the addition of ivonescimab also showed an improvement in intracranial PFS over control arm with 15.7 months compared to 11.6 months (HR 0.72 (0.55-0.94); nominal p=0.0172). No new safety signals were identified across baseline brain metastasis subgroups.

The second poster, "Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy" includes data from patients enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI.

The third poster, "Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): a Randomised, Double-Blind, Phase 3 Study in China" includes data from patients enrolled in HARMONi-2 or AK112-303 (NCT05499390). These patients received either ivonescimab delivered as monotherapy, or pembrolizumab delivered as monotherapy in this Phase III study conducted exclusively in China for patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression with all data collected and analyzed by Akeso.

About the ELCC 2026 Posters

Poster Title: Intracranial Efficacy of Ivonescimab Plus Chemotherapy in EGFR TKI-Resistant, EGFR-Mutated NSCLC in the HARMONi Study
ELCC Presentation No.: 15P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

Poster Title: Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy
ELCC Presentation No.: 20P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

Poster Title: Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): A Randomised, Double-Blind, Phase 3 Study in China
ELCC Presentation No.: 107P
Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, MAR 27, 2026, View Source [SID1234663986])

On March 27, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the presentation of new clinical data for ZEGFROVY (sunvozertinib) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) P-Loop and αC-helix compressing (PACC) or other uncommon mutations. The data were presented at the 2026 European Lung Cancer Congress (ELCC), held in Copenhagen, Denmark from March 25 to 28 (#44P).

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PACC mutations account for approximately 12.5% of all EGFR mutations. Approved EGFR kinase inhibitors may have clinical activities to certain types of mutations, but overall, their clinical benefits are rather limited, and chemo doublet are the only option. Multiple studies have shown that patients with these mutations exhibit poorer prognosis than those with classical EGFR common mutations (exon 19 deletions and L858R), underscoring a significant unmet medical need for effective, well-tolerated therapies with broader activity cross the EGFR mutation spectrum.

ZEGFROVY, a rationally designed oral EGFR TKI, has demonstrated robust clinical efficacy in advanced NSCLC and potent antitumor activity in preclinical models of EGFR PACC-mutant tumors. At the recommended phase 3 dose (RP3D) of 300 mg, ZEGFROVY monotherapy demonstrated promising antitumor activity and a manageable safety profile in treatment-naïve patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations.

Per investigator assessment, tumor lesion shrinkage was observed in 100% of patients, with an overall response rate (ORR) of 81.3%, and a disease control rate (DCR) of 100%.
Tumor response was also observed in 11 out of 15 patients with previously-untreated baseline brain metastasis (BM), including 6 patients with confirmed partial response (PR).
The antitumor activity was durable. As of the data-cut-off (DCO) date, median duration of response (DoR) had not been reached, with 81.3% of patients remaining on ZEGFROVY treatment. The estimated 6-month durable response rate was 87.5%.
Progression-free survival (PFS) was not mature. The estimated 9-month PFS rate was 83.9%.
The safety profile was consistent with previous studies of ZEGFROVY. No new safety signals were observed.
Dr. Xiaolin Zhang, CEO of Dizal, said: "NSCLC patients with EGFR PACC and other uncommon mutations represent a population with substantial unmet medical need, given the limited availability of effective and well-tolerated target therapies, compared to those available for classical EGFR mutations. The data presented at ELCC further reinforces the potential of ZEGFROVY to address this gap. We are committed to advancing our clinical development programs, with the goal of bringing transformative treatment options to the global lung cancer community as quickly as possible."

ZEGFROVY is approved in the U.S. and China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins. Recently, Dizal reported the results from the randomized Phase 3 WU-KONG28 study, comparing ZEGFROVY monotherapy with platinum containing chemo doublet. ZEGFROVY showed a statistically significant and clinically meaningful improvement in PFS in newly diagnosed patients with EGFR exon20ins. Detailed results will be presented at the upcoming scientific conference.

About ZEGFROVY(sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.

(Press release, Dizal Pharma, MAR 27, 2026, View Source [SID1234663985])

On March 27, 2026 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported it will host its March Stakeholder Webcast focused on continued progress of its botensilimab and balstilimab (BOT+BAL) immunotherapy program and will provide an update on the Company’s patient access programs, development across tumor types, and key priorities for 2026.

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The session will be moderated by Garo H. Armen, PhD, Founder, Chairman, and Chief Executive Officer of Agenus, and will conclude with a live Q&A.

Featured Topics and Speakers

Strategic Direction: Advancing BOT+BAL
Garo Armen, PhD
Founder, Chairman, and Chief Executive Officer, Agenus
Dr. Armen will open the session by discussing Agenus’ mission to harness the immune system across tumor types and the urgency of advancing new options for patients with historically treatment-resistant cancers. He will also outline key priorities for 2026 as momentum continues to build across the BOT+BAL program.

Clinical Progress: Durability and Consistency Across Tumors
Steven J. O’Day, MD
Chief Medical Officer, Agenus
Dr. O’Day will provide a clinical perspective on the durability and consistency of BOT+BAL across tumor types, including in historically immunotherapy-resistant cancers. He will also highlight how these data are informing ongoing development and later-stage trials.

Access and Execution: Expanding Patient Through Available Global Programs
Kamel Djazouli, MD
Head, Medical Affairs, Agenus
Dr. Djazouli will provide an update on Agenus’ global access programs, including the France AAC and Named Patient Programs, and how they are enabling treatment for patients with limited options.
Stakeholder Briefing Details:

Registration Link: View Source
Live webcast link will be provided once registration is completed.

Submit questions in advance at: View Source

This session marks the second event in Agenus’ 2026 Stakeholder Briefing Series, building on prior discussions regarding BOT+BAL’s clinical progress, patient access pathways, and Agenus corporate milestones.

(Press release, Agenus, MAR 27, 2026, View Source;BAL-Across-Tumor-Types-and-Expand-Patient-Access/default.aspx [SID1234663984])

On March 27, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the fourth quarter and year ended December 31, 2025.

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"We have initiated a process to explore a range of alternatives available to the Company to maximize stockholder value," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Such measures may include, among other options, a sale of the Company, a business combination or merger, a sale of assets, licensing or collaboration arrangements, or other strategic transactions. In addition to our clinical-stage candidates and our named earlier- stage candidates, our INDUKINE and INDUCER platforms provide exciting opportunities to apply our differentiated masking and protease linker technology in multiple additional modalities."

The Company has engaged Piper Sandler & Co. ("Piper Sandler") to serve as exclusive financial advisor to assist in the strategic evaluation process. The Company does not have a defined timeline for the exploration and evaluation of strategic alternatives and cannot confirm that the process will result in any strategic alternative being announced or consummated. The Company cannot provide any commitment regarding when or if this strategic evaluation process will result in any type of transaction, and there can be no assurance that such activities will result in any agreements or transactions that will enhance stockholder value. The Company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or the Company has otherwise determined that further disclosure is appropriate.

Financial Results for the Fourth Quarter and Full Year 2025:

•Cash position: As of December 31, 2025, cash and cash equivalents were $57.1 million, compared to $65.7 million as of September 30, 2025. The Company believes its cash and cash equivalents as of December 31, 2025, will be sufficient to fund operational expenses and capital requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $6.9 million for the fourth quarter of 2025, compared to $15.7 million for the same period in 2024. Research and development expenses were $44.8 million for the full year 2025, compared to $56.4 million for the full year 2024.
•General and administrative expenses: General and administrative expenses were $2.5 million for the fourth quarter of 2025, compared to $4.6 million for the same period in 2024. General and administrative expenses were $15.8 million for the full year 2025, compared to $19.0 million for the full year 2024.
•Net loss: Net loss was $8.4 million for the fourth quarter of 2025, compared to $20.4 million for the same period in 2024. Net loss was $60.8 million for the full year 2025, compared to $70.5 million for the full year 2024.

(Press release, Werewolf Therapeutics, MAR 27, 2026, View Source [SID1234663982])

On March 27, 2026 PharmaMar (MSE: PHM), reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as first-line maintenance therapy for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after standard induction therapy.

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The CHMP’s positive opinion is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals in which the combination of lurbinectedin and atezolizumab was associated with a 46% reduction in the risk of disease progression or death, and a 27% reduction in the risk of death compared with atezolizumab monotherapy.

Dr. Luis Paz-Ares, Head of the Medical Oncology Service at the 12 de Octubre University Hospital in Madrid and principal investigator of the IMforte trial, highlights that: "This positive opinion represents a significant step forward in providing patients in Europe with access to an innovative therapy for a disease with a particularly poor prognosis. For the first time in this maintenance context, an improvement in overall survival and progression-free survival has been demonstrated, marking a milestone in the treatment of this disease. For healthcare professionals, this advancement provides a new treatment option to offer our patients."

Luis Mora, Managing Director of PharmaMar, commented: "The CHMP’s positive opinion represents a very important milestone in facilitating access for European patients to a new therapeutic option. It also represents important recognition of our Company’s commitment to research and development of innovative new compounds."

The European Commission will now decide on the marketing authorization in accordance with the established procedure. This combination is currently authorized for first-line maintenance treatment in 10 countries including the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel and Taiwan.

Following a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the EMA, lurbinectedin has been approved as an Orphan Medicinal Product for small cell lung cancer. Orphan drug designation is a status granted by the EMA to drugs intended to treat rare or uncommon diseases that affect fewer than 5 people per 10,000 inhabitants in the European Union.

Small cell lung cancer accounts for about 15% of lung cancer cases and is characterized by its aggressive behavior, and an early tendency to spread[i],[ii]. Each year, around 62,000 new cases of SCLC[iii] are diagnosed in Europe,with most patients presenting advanced disease at the time of diagnosis.

(Press release, PharmaMar, MAR 27, 2026, View Source [SID1234663981])