On May 22, 2026 Boehringer Ingelheim reported HERNEXEOS (zongertinib tablets) has been conditionally approved as monotherapy by China’s National Medical Products Administration (NMPA) as an initial treatment for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.1 The approval is based on data demonstrating a 75.7% objective response rate, with full approval contingent on confirmation of clinical benefit in an ongoing trial. It represents another major milestone following the Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s NMPA for first-line treatment.4 The therapy is also approved for patients in China who have received prior treatment.

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"In the past, patients with HER2‑mutant advanced non-small cell lung cancer faced significant diagnostic and treatment challenges in clinical practice. These challenges not only placed considerable physical and psychological burdens on patients but also limited the delivery of precise lung cancer treatment," said Professor Yi-Long Wu from Guangdong Provincial People’s Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG). "This advancement directly addresses patients’ core clinical needs for quality care."

The approval is based on data from a cohort of treatment-naïve patients (N=74) in the Phase Ib Beamion LUNG-1 trial, which demonstrated an objective response rate (ORR) of 75.7%, including 10.8% achieving complete response (CR) and 64.9% achieving partial response (PR). The median duration of response (mDoR) was 15.2 months. Treatment-related adverse events (AEs) were predominantly low-grade. In a pooled safety population, which included 177 patients with HER2 (ERBB2)-mutant NSCLC in Beamion LUNG-1, AEs led to dose reductions in 9% of patients and dose discontinuations in 6% of patients. Data for treatment-naive patients were presented at the European Lung Cancer Congress 2026 (ELCC 2026) and published in The New England Journal of Medicine.

"The first-line approval of HERNEXEOS in China marks an important step forward in our ambition to redefine the treatment of HER2-driven cancers," said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim. "Building on strong global momentum, including approvals in the U.S., and supported by compelling clinical evidence, we are advancing this therapy across various stages of disease and tumor types. This milestone reflects not only the progress we have made, but the broader opportunity ahead – to deliver unprecedented impact for people living with cancer, now and for generations to come."

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type7 and the incidence is set to increase to over 3 million cases worldwide by 2040.8 NSCLC is the most common type of lung cancer.7 The condition is often diagnosed at a late stage9, and fewer than 3 in 10 patients are alive five years after diagnosis.9,10 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,11,12

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).7 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.13

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities. HERNEXEOS is approved in the U.S., China, Hong Kong and Japan as the first orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as an initial treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, MAY 22, 2026, View Source [SID1234666017])

On May 22, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, reported translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

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"These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens," said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. "This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers."

"KRAS-mutant tumors remain among the most challenging to treat with immunotherapy," said Jared Kelly, Chief Executive Officer of Oncolytics. "These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed."

Abstract: Influence of pelareorep on mutant KRAS-specific blood TIL clonal expansion.
Author: Richard Trauger, PhD
Date: May 30, 2026, 1:30-4:30 p.m. Central Time
Abstract Number: 2664
Poster Board Number: 454

Translational analyses from the Phase 1/2 GOBLET study in advanced pancreatic cancer and the AWARE-1 window-of-opportunity study in early-stage breast cancer illustrate a multi‑step immune activation process following treatment with pelareorep. Results demonstrate that pelareorep induces an antiviral immune response within the tumor via double-stranded RNA signaling, leading to expansion of virus‑specific T cells and subsequent activation of tumor‑specific T cells associated with tumor regression.

In pancreatic cancer, serial blood analyses demonstrated expansion of anti‑viral T cells by ELISPOT and clonal expansion of tumor‑specific T cells after one cycle of therapy. Notably, the expansion of pre‑existing tumor‑infiltrating lymphocyte ("TIL") clones in blood correlated with reductions in tumor volume in pancreatic cancer. T‑cell receptor sequencing with antigen specificity assessment confirmed expansion of mutant KRAS-specific T‑cell clones, supporting a model in which pelareorep engages both innate and adaptive immunity and may help drive tumor‑directed immune responses in difficult‑to‑treat, KRAS‑driven disease.

In serial breast tumor biopsies, gene expression profiling demonstrated significant increases in antiviral and immune gene expression, consistent with activation of toll‑like receptor 3 (TLR3), alongside induction of CXCL13, a chemokine linked to the formation of tertiary lymphoid structures (TLS). TLS formation in the tumor microenvironment was further supported by imaging mass cytometry following treatment. Across studies, evidence of the expansion of TILs was observed in the tumor and the blood.

A copy of the ASCO (Free ASCO Whitepaper) presentation will be available on the Media page of the Oncolytics’ website following the conclusion of the meeting.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

Pelareorep in combination with atezolizumab (Tecentriq), gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH ("AIO") emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.

(Press release, Oncolytics Biotech, MAY 22, 2026, View Source [SID1234666016])

On May 22, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that it will host a conference call and webcast on Monday, June 1, 2026 at 8:30 a.m. ET to discuss data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests that will be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. This includes results from the OPTIMA and ENZAMET trials.

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Professor Iain Macpherson, one of the principal investigators of OPTIMA, Professor of Breast Oncology at the University of Glasgow and Honorary Consultant Medical Oncologist at the Beatson West of Scotland Cancer Centre, will join for the discussion.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source A webcast replay will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-ins can be accessed by registering via this link.

(Press release, Veracyte, MAY 22, 2026, View Source [SID1234666015])

On May 22, 2026 Oxford Vacmedix (OVM), the UK biotech company developing novel immunotherapies to treat cancer reported that the Phase 1b dose expansion part of the Phase 1 trial of OVM-200 will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago at the end of May. The poster presentation will be part of the session on Developmental Therapeutics – Immunotherapy. This follows the publication of Phase 1a, which established dosing, in a Lancet group journal earlier this year.

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This Phase 1 clinical trial of OVM-200 is a multicentre, open-label, first-in-human evaluation of OVM-200, an immunotherapy developed using Oxford Vacmedix’s Recombinant Overlapping Peptide (ROP) therapeutic platform. 36 patients with advanced NSCLC (non-small cell lung cancer) ovarian cancer, or prostate cancer and with no HLA restrictions, were treated in the trial. The results show:

Excellent Safety Profile (primary endpoint): OVM-200 is very well tolerated with no serious adverse drug reactions or no dose-limiting toxicities. The only adverse effects were Grade 1 injection-site reactions.
Very strong Immunogenicity (secondary endpoint): the immune responses for both antibodies and for T cells were very strong even in an advanced Stage IV patient population.
Therapeutic Dose established (secondary endpoint) based on the immune response, the 2mg dose selected in Phase 1a was chosen for expanded immunisations of up to 11 doses of 2mg in Phase 1b.
Early observations of clinical efficacy with stable disease in NSCLC and PSA responses in prostate cancer following progression to other therapies.
Professor Martin Forster, Chief Investigator at University College Hospital, London, said:

We are very impressed with the results of this Phase 1 trial for OVM-200. In particular, seeing six months stable disease in a Stage IV lung cancer patient is a very promising result, for follow up. We look forward to further development with Phase 2 trials of OVM-200.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

The completion of this clinical trial of OVM-200 marks an important milestone for the company. We are of course very grateful for the participation of the patients and the dedication of the staff in the clinics in this first trial of OVM-200. We are already in discussions about investment to fund Phase 2 development.

(Press release, Oxford Vacmedix, MAY 22, 2026, View Source;utm_medium=rss&utm_campaign=ovm-200-phase-1-clinical-trial-accepted-for-presentation-at-asco [SID1234666014])

On May 22, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported preliminary results from a new health economic analysis demonstrating that ANKTIVA (nogapendekin alfa inbakicept-pmln; NAI) plus Bacillus Calmette–Guérin (BCG) achieved a lower cost per sustained complete responder compared to TAR-200 in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ ± papillary disease (NMIBC CIS). The findings were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2026, May 17–20, 2026, at the Pennsylvania Convention Center in Philadelphia, by Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health.

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The authors developed a cost-consequence model comparing ANKTIVA plus BCG, using data from the QUILT-3.032 study, with TAR-200, using data from the SunRISe-1 trial, and evaluated both clinical and economic outcomes in a U.S. Medicare population. A multi-state Markov model incorporating key NMIBC health states and clinical outcomes derived from a matched-adjusted indirect comparison (MAIC) of the two trials was used to assess costs associated with treatment acquisition, administration, healthcare resource utilization, radical cystectomy, and mortality.

Key findings include:

Cost per cystectomy avoided: ANKTIVA plus BCG demonstrated savings of $109,622 at Year 1, $151,438 at Year 2, and $60,393 at Year 3 compared to TAR-200
Cost per cystectomy-free month: Savings of $9,370 at Year 1, $6,144 at Year 2, and $1,520 at Year 3
Cost per complete responder: Savings of $313,775 at Year 1 and $282,013 at Year 2
Cost reductions were primarily driven by lower drug acquisition and administration costs, based on complete response rates derived from an indirect treatment comparison—49.6% for ANKTIVA plus BCG versus 45.9% for TAR-200.

The authors concluded that ANKTIVA plus BCG offers direct cost savings across measurable clinical outcomes for patients with BCG-unresponsive NMIBC CIS compared to TAR-200 in a U.S. Medicare population, with savings persisting across all three years of the analysis.

"This health economic analysis reflects our dual mission of developing breakthrough immunotherapies that meaningfully extend lives, while ensuring these innovations are accessible within the broader healthcare landscape. By analyzing the rigorous economic efficiencies of our treatments, we are better positioned to ensure more patients can receive the most innovative and accessible cancer treatments available today," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "These results solidify the potential value of ANKTIVA plus BCG in delivering durable responses while reducing costs to the Medicare healthcare system."

"These findings reinforce the importance of aligning clinical innovation with both economic value and patient preferences," said Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health. "In BCG-unresponsive NMIBC, treatment decisions are not solely about response rates; they are about durability, quality of life, and ensuring patients have access to therapies that are both effective and sustainable within the healthcare system."

About BCG-Unresponsive NMIBC CIS

Non-muscle-invasive bladder cancer (NMIBC) represents approximately 75% of all bladder cancer diagnoses in the United States. Patients with carcinoma in situ (CIS) who become unresponsive to BCG therapy face a high risk of recurrence and progression and often have limited bladder-sparing treatment options available.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAY 22, 2026, View Source [SID1234666013])