On October 13, 2025 Aveta Biomics, a clinicalstage biotechnology company developing first-in-class drugs that reprogram the immune system to fight cancer, reported the poster presentation of new clinical and translational findings from its Phase IIa study of APG-157 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 17–21, 2025, in Berlin, Germany (Press release, Aveta Biomics, OCT 13, 2025, View Source [SID1234656579]).

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The company’s poster will highlight data from patients with head and neck squamous cell carcinoma (HNSCC) treated with oral APG-157 as neoadjuvant or induction monotherapy. The results provide the first detailed mechanistic evidence of how APG-157 reshapes the immunecold tumor microenvironment (TME) into an immune-engaged, "hot" state correlating with the observed Event-Free Survival (EFS) outcomes.

"These translational data provide unprecedented insight into APG-157’s multi-axis immune reprogramming in head and neck cancer," said Selda Samakoglu, M.D., Ph.D., Chief Medical Officer of Aveta Biomics. "They reveal how APG-157 orchestrates effector and helper T-cell coordination, collapses PD-L1⁺ epithelial barriers, and repolarizes suppressive macrophages. This mechanism appears to drive the durable responses observed in our Phase IIa study and reinforces the rationale for advancing APG-157 as a monotherapy into our registrational Phase III trial next year."

"The implications of these findings extend well beyond head and neck cancer," added Luis Avila, Ph.D., Chief Scientific Officer of Aveta Biomics. "The broad immune remodeling coupled with the excellent safety profile observed in Phase IIa defines a new therapeutic paradigm. These results support APG-157’s potential as a PD-1–independent, oral immunotherapy capable of producing durable responses across multiple tumor types and enhancing the effectiveness of existing immunotherapies."

PRESENTATION DETAILS:

TITLE: Spatial Profiling of Immune Architecture Reveals APG-157-Induced Anti-Tumor Immune Remodeling in Locally Advanced Head and Neck Cancer

ABSTRACT NUMBER: 1401P
SESSION TITLE: Head and Neck Cancer, excluding Thyroid
LOCATION: Messe Berlin, Poster Area, Hall 25
SESSION DATE AND TIME: Monday, October 20, 2025, 9:00 AM – 12:45 PM

PRESENTERS: • Daniel S. Shin, MD, PhD, Associate Professor, Hematology-Oncology, Baylor College of Medicine, Houston, Texas • Selda Samakoglu, MD, PhD, Chief Medical Officer, Aveta Biomics, Inc.

On October 13, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported it will demonstrate progress in its commitment to transform how cancer is treated with new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress October 17 – 21 (Press release, Gilead Sciences, OCT 13, 2025, View Source [SID1234656595]).

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Potentially Practice-Changing Results for First-Line Metastatic TNBC Treatment

A late-breaking presentation (#LBA20) will feature full results from the Phase 3 ASCENT-03 study of Trodelvy (sacituzumab govitecan-hziy) as a first-line treatment in people with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors. Gilead previously announced that ASCENT-03 met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Trodelvy compared to chemotherapy in this patient population, potentially offering the first major treatment advance for this patient population since TNBC was classified as a disease 20 years ago.

Late-breaking results will also be presented (#LBA22) from an analysis evaluating quality of life among patients receiving Trodelvy plus Keytruda (pembrolizumab) versus Keytruda and chemotherapy in the positive ASCENT-04/KEYNOTE-D19 study in first-line PD-L1+ metastatic TNBC. Primary results from the ASCENT-04 study were recently presented during a late-breaking oral session at the 2025 ASCO (Free ASCO Whitepaper) Annual Congress.

The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

"With ASCENT-04 and now ASCENT-03, our data underscore the potential of Trodelvy to be a standard of care option for all first-line metastatic triple-negative breast cancer patients regardless of PD-L1 status," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "This progress reflects our broader oncology strategy – advancing innovative therapies into earlier lines of treatment, expanding the types of cancer we can treat and applying the very latest innovation to the most challenging forms of cancer, including gastroesophageal, lung and gynecological cancers."

Expanding Impact in Gastric and Esophageal Cancers

Together with Arcus Biosciences, Gilead will also share the first overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study (#2112MO) evaluating first-line, combination treatment of the Fc-silent anti-TIGIT antibody domvanalimab, plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in people with advanced gastric or esophageal cancer that has spread or cannot be removed with surgery. In Arm A1 of the study, 50 percent of patients went on to live for more than two years, with a median OS of 26.7 months.

No unexpected safety signals were observed at the time of data cut off. The safety profile of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and is consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated TEAEs related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions occurred in 3 patients (7%).

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

Summary of Presentations

Accepted abstracts at ESMO (Free ESMO Whitepaper) 2025 include (all times CEST):

Title

Details

Breast Cancer

Primary Results From ASCENT-03: A Randomized Phase 3 Study of Sacituzumab Govitecan (SG) vs Chemotherapy (Chemo) in Patients (pts) With Previously Untreated Advanced Triple-Negative Breast Cancer (TNBC) Who Are Not Candidates for PD-(L)1 Inhibitors (PD-[L]1i)

Abstract #LBA20

Proffered Paper Session

October 19, 2025

9:15 – 9:25 AM

Patient-reported outcomes (PROs) with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in patients (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) in the phase 3 ASCENT-04/KEYNOTE-D19 study

Abstract #LBA22

Mini Oral Session

October 20, 2025

10:15 – 10:20 AM

Identifying unresectable locally advanced or metastatic hormone receptor-positive/HER2-negative and triple-negative breast cancer in the French National Healthcare Data System (SNDS)

Abstract #588P

Poster Session

October 20, 2025

12:00 – 12:45 PM

Gastric and Esophageal Cancer

Domvanalimab (dom), zimberelimab (zim), and FOLFOX in first-line (1L) advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma (GC/GEJC/EAC): 26-month update from EDGE-Gastric, Arm A1

Abstract #2112MO

Mini Oral Session

October 18, 2025

10:45 – 10:50 AM

Lung Cancer

Phase 2 study of sacituzumab govitecan (SG), domvanalimab (dom), and zimberelimab (zim) in metastatic non-small cell lung cancer (mNSCLC): VELOCITY-Lung Substudy-01

Abstract #1947P

Poster Session

October 18, 2025

12:00 – 12:45 PM

Long-term safety profile of sacituzumab govitecan (SG) vs docetaxel in patients (Pts) with metastatic non-small cell lung cancer (mNSCLC) from EVOKE-01

Abstract #1952P

Poster Session

October 18, 2025

12:00 – 12:45 PM

Real-world analyses to evaluate the role of TIGIT as a target in first-line (1L) metastatic non-small cell lung cancer (mNSCLC)

Abstract #1885P

Poster Session

October 18, 2025

12:00 – 12:45 PM

Head and Neck Cancer

PD-L1 expression in head and neck squamous cell carcinoma (HNSCC): agreement between SP263 and 22C3 and correlation with TIGIT and CD155 (PVR)

Abstract #1415P

Poster Session

October 20, 2025

12:00 – 12:45 PM

Large B-cell Lymphoma

A German perspective on the cost-effectiveness of axicabtagene ciloleucel versus standard of care as second-line therapy in patients with large B-cell lymphoma

Abstract #1282P

Poster Session

October 18, 2025

12:00 – 12:45 PM

A two-step Costing Analysis of CAR T-Cell Therapy versus Autologous Stem Cell Transplantation for DLBCL in Germany

Abstract #1268P

Poster Session

October 18, 2025

12:00 – 12:45 PM

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

Indications for Trodelvy

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

On October 12, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations and CNS involvement (Press release, Taiho, OCT 12, 2025, View Source [SID1234656562]). Data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, as a mini oral presentation on October 19 during the "NSCLC metastatic" session from 8:30 to 10 a.m. CEST.

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The mini oral presentation will highlight preliminary efficacy and safety data from the CNS involvement cohort of the ongoing parallel cohort Phase 2b REZILIENT2 trial of zipalertinib.1

Patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations represent a significant unmet medical need. An incidence of baseline brain metastases in EGFR ex20ins NSCLC patients ranging from 23% to 39% has been reported.² Patients with lung cancer with CNS involvement have a worse prognosis and require more aggressive therapy, including surgery and radiotherapy.

"Treatment options are limited for patients with NSCLC with EGFR mutations and active brain metastases," said Helena A. Yu, MD, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer. "We are pleased to see that in approximately one-third of patients exposed to zipalertinib, a decrease in CNS lesions was observed. These preliminary results suggest the potential for zipalertinib to treat these patients, warranting future investigation."

Authors will report results from the REZILIENT2 study of zipalertinib against active CNS metastases in patients with NSCLC harboring EGFR ex20ins or other uncommon mutations1:

Summary of Preliminary Efficacy – by Investigator

As of the February 2025 data cutoff, 32 patients were enrolled in the CNS involvement cohort of the ongoing parallel cohort Phase 2b REZILIENT2 trial and received zipalertinib 100 mg orally twice daily. Patients received a median of 2 prior lines of therapy, and of all patients enrolled, 21 patients had ex20ins mutations and 13 patients had other uncommon mutations.

As of the data cutoff, zipalertinib demonstrated:

In the Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) criteria evaluable population with measurable CNS disease (n=16, including 3 patients with leptomeningeal disease (LMD), intracranial objective response rate was 31.3% including 1 intracranial complete response.
In the same population, the intracranial disease control rate (iDCR) was 68.8% and the median intracranial duration of response (DOR) was 8.1 months.
Measured in 29 of the cohort’s patients, preliminary systemic objective response rate (ORR) was 27.6% and median DOR was 7.6 months.
Intracranial antitumor activity was found to be similar to its overall systemic anticancer activity in this cohort of patients.
Summary of Preliminary Safety and Tolerability

Administered at 100 mg orally twice daily, zipalertinib was found to be well tolerated, with no new safety signals observed.

Treatment-related adverse events of grade 3 or higher occurred in 8 patients (25%) and included anemia (n=3) and interstitial lung disease (n=2). There was one death due to interstitial lung disease.

About REZILIENT2
REZILIENT2 is a Phase 2b clinical trial (NCT05967689), evaluating the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring ex20ins mutations or other uncommon/single or compound EGFR mutations. Patients are enrolled into one of four cohorts: Cohort A ("prior ex20ins treatment"), Cohort B ("first-line"), Cohort C ("active brain metastases"), and Cohort D ("other uncommon EGFR mutations"). Cohort C includes patients harboring EFGR ex20ins or other uncommon/single or compound EGFR mutations and CNS involvement. In this cohort, patients may or may not have had prior treatment for advanced disease. Patients are treated with oral zipalertinib 100 mg twice daily. The primary endpoint is ORR and confirmed per investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and the secondary endpoints include DOR, DCR, PFS, OS, intracranial efficacy by RANO-BM criteria, PK and safety.

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with ex20ins mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On October 12, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported a presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany, from October 17-21, 2025 (Press release, Advancell, OCT 12, 2025, View Source [SID1234656564]).

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The presentation will feature promising results from the Phase 1b dose escalation of the Phase 1/2 TheraPb study, evaluating ADVC001, a Lead-212-based PSMA-targeted alpha therapy, in metastatic castration-resistant prostate cancer (mCRPC).

This will be the first presentation of clinical data from a 212Pb-PSMA therapy at a major oncology conference – an important milestone in advancing targeted alpha therapies for prostate cancer and a clear demonstration of AdvanCell’s leadership in radioligand therapy. The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with metastatic prostate cancer.

The abstract is available online on the ESMO (Free ESMO Whitepaper) website (link), and features data as of a May 9, 2025 cut-off. The poster to be presented at ESMO (Free ESMO Whitepaper) will include updated safety and efficacy data and additional treatment cohorts.

Details of the abstract and presentation:

Results from the Phase 1b Dose Escalation of 212Pb-ADVC001 in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC): The TheraPb Trial

Presenter: Aaron Hansen, MD, BSc, MBBS, FRACP, Princess Alexandra Hospital, Brisbane, Australia
Presentation Number: 2388P
Session: Prostate Cancer Poster Session
Session Time/ Place: Saturday, October 18 / 12:00-12:45 PM CET / Hall 25
Poster Display Time: 9:00 AM – 5:00 PM CET
About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose-escalation and expansion study designed to determine the safety and tolerability of escalating doses of 212Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) during the dose-finding Phase 1b. The Phase 2 expansion will assess the efficacy and safety of 212Pb-ADVC001 at the recommended Phase 2 doses across three indications. The trial incorporates randomization and dose optimization elements to rigorously evaluate optimal dosing strategies of 212Pb-ADVC001 in PSMA-positive mCRPC and in hormone-sensitive prostate cancer (mHSPC).

About 212Pb-ADVC001

212Pb-ADVC001 is a novel, proprietary and patented small molecule PSMA-targeting radioligand with optimized physicochemical properties labelled with 212Pb, an alpha-emitting payload (radionuclide) with a high dose rate, short half-life (10.6 hours) and simple decay scheme. 212Pb-ADVC001 is designed to deliver radiation at a cellular level to more effectively kill prostate cancer cells while minimizing toxicity.

On October 12, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, held October 17-21, 2025 in Berlin, Germany (Press release, Genentech, OCT 12, 2025, View Source [SID1234656587]). The data underscore Genentech’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers.

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Key presentations include:

Giredestrant: Primary results from the Phase III evERA Breast Cancer study, the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor (ER) degrader-containing regimen versus a standard of care combination in the post-cyclin-dependent kinase inhibitor setting for people with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations. Data will be presented as a late-breaking oral abstract.
Tecentriq: Results from the IMvigor011 trial, the first global Phase III study pioneering a circulating tumor DNA (ctDNA)-guided approach to post-surgery treatment in muscle-invasive bladder cancer (MIBC). Topline results show that people who had detectable ctDNA and were treated with Tecentriq (atezolizumab) had statistically significant and clinically meaningful improvements in disease-free survival (DFS) and overall survival (OS). Data will be presented as part of the Presidential Symposium.
Alecensa: Final OS data from the pivotal ALEX study of Alecensa (alectinib). Alecensa is an established first-line treatment and a standard of care for people with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Data will be presented as a late-breaking oral abstract and published simultaneously in the Annals of Oncology.
Alecensa: Updated results from the Phase III ALINA study, reinforcing the role of adjuvant Alecensa as the standard of care for patients with resected ALK-positive NSCLC. After a median follow-up of approximately four years, Alecensa DFS data compared with chemotherapy will be presented.
Overview of key presentations featuring Genentech medicines:

Medicine

Abstract title

Abstract number/presentation details

Breast cancer

Giredestrant

Giredestrant (GIRE), an oral selective estrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2- aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial

#LBA16 late-breaking oral

Proffered paper session 1: Breast cancer, metastatic

Saturday 18 October 2025

10:15-10:25 CEST

Preoperative window-of-opportunity study with giredestrant or tamoxifen (tam) in premenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) and Ki67≥10% early breast cancer (EBC): the EMPRESS study (IIS: MEDSIR)*

#294MO mini oral

Mini oral session: Breast cancer, early stage

Sunday 19 October 2025

10:50-10:55 CEST

Giredestrant plus Itovebi (inavolisib)

Interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS breast cancer (BC): A Phase Ib/II study of GIRE treatment (rx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC)

#508P poster

Poster session: Breast cancer, metastatic

Monday 20 October 2025

12:00-17:30 CEST

Itovebi

Phase I/Ib trial of inavolisib (INAVO) + pertuzumab (P) + trastuzumab (H) for PIK3CA-mutated (mut), HER2-positive advanced breast cancer (HER2+ aBC)

#548P poster

Poster session: Breast cancer, metastatic

Monday 20 October 2025

12:00-17:30 CEST

Genitourinary cancer

Tecentriq (atezolizumab)

IMvigor011: a Phase III trial of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

#LBA8 late-breaking oral

Presidential Symposium III

Monday 20 October 2025

16:30-16:42 CEST

Lung cancer

Alecensa (alectinib)

Final overall survival (OS) and safety analysis of the Phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC)

#LBA73 late-breaking oral

Proffered paper session: NSCLC metastatic

Friday 17 October 2025

17:06-17:16 CEST

Updated results from the Phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC)

#1787MO mini oral

Mini oral session 2: Non-metastatic NSCLC

Monday 20 October 2025

14:50-14:55 CEST

Tecentriq

Patterns of disease progression (PD) and efficacy associated with tumor burden from the Phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L)
maintenance treatment (tx) in ES-SCLC

#2762MO mini oral

Mini Oral session 1: Non-metastatic NSCLC

Saturday 18 October 2025

17:15-17:20 CEST

Gastrointestinal cancer

Tecentriq

(IIS: NCI, Alliance)**

Clinical outcome of patients (pts) with sporadic vs Lynch syndrome-related stage III colon carcinoma (CC) with deficient mismatch repair (dMMR) treated in a randomized trial of adjuvant FOLFOX alone or combined with atezolizumab (atezo; anti-PD-L1)

#752P poster

Poster session: Colorectal cancer

Sunday 19 October 2025

Divarasib

Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors

#927MO mini oral

Mini oral session: Developmental therapeutics

Friday 17 October 2025

17:00-17:05 CEST

* Investigator Initiated Study (IIS). The study is sponsored by MEDSIR and supported by Genentech, a member of the Roche Group.

** Investigator Initiated Study (IIS). The study is sponsored by the National Cancer Institute (NCI), conducted by the Alliance for Clinical Trials in Oncology and supported by Genentech, a member of the Roche Group.

What is Itovebi?

Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
difficulty breathing
nausea and vomiting (lasting more than 2 hours)
stomach pain
excessive thirst
dry mouth
more frequent urination than usual or a higher amount of urine than normal
blurred vision
unusually increased appetite
weight loss
fruity-smelling breath
flushed face and dry skin
feeling unusually sleepy or tired
confusion
Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
pain
redness
swelling
ulcers
Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

decreased white blood cell counts, red blood cell counts, and platelet counts
decreased blood levels of calcium, potassium, sodium, and magnesium
increased creatinine blood levels
tiredness
increased blood levels of the liver enzyme alanine transaminase (ALT)
nausea
rash
loss of appetite
COVID-19 infection
headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

have a history of diabetes or high blood sugar
have kidney problems
are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.
Males with female partners who are able to become pregnant:

You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information.

Who is Alecensa for?

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

To help prevent lung cancer from coming back in patients after their tumor has been removed by surgery (adjuvant), or
As treatment if your lung cancer has spread to other parts of the body (metastatic).

Your doctor will perform a test to make sure that Alecensa is right for you. It is not known if Alecensa is safe and effective in children.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

Your doctor may lower the dose or stop treatment with Alecensa if any side effects occur. Contact your doctor right away if you have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with Alecensa. Tell your doctor right away if you get any of the following signs and symptoms:

Feeling tired
Feeling less hungry than usual
Yellowing of the skin or whites of the eyes
Dark urine
Itchy skin
Nausea or vomiting
Pain on the right side of stomach area
Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. Alecensa may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or if they faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor right away if you have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop Alecensa and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on Alecensa at a lower dose when the hemolytic anemia goes away, or may stop your treatment with Alecensa. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

What should I tell my doctor before taking ALECENSA?

Before you take Alecensa, tell your doctor about all of your medical conditions, including if you:

have liver problems
have lung or breathing problems
have a slow heartbeat
are pregnant or plan to become pregnant. Alecensa can harm an unborn baby.
Females who are able to become pregnant:

Your doctor will do a test to see if you are pregnant before starting treatment with Alecensa
You should use effective birth control (contraception) during treatment with Alecensa and for 5 weeks after the last dose of Alecensa
Tell your doctor right away if you become pregnant during treatment with Alecensa or think you may be pregnant
Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Alecensa and for 3 months after the last dose of Alecensa

Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into your breast milk. Do not breastfeed during treatment with Alecensa and for 1 week after the last dose of Alecensa. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking Alecensa?

Avoid spending time in the sunlight during treatment with Alecensa and for 7 days after the final dose of Alecensa. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

constipation
tiredness
swelling in hands, feet, ankles, face, and eyelids
rash
cough

These are not all of the possible side effects of Alecensa. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or View Source Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

What is Tecentriq?

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called "extensive stage small cell lung cancer (SCLC)", which is SCLC that has spread or grown

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
Tecentriq may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
has not progressed after first treatment with TECENTRIQ or atezolizumab and hyaluronidase-tqjs and the chemotherapy medicines carboplatin and etoposide.

It is not known if Tecentriq is safe and effective when used:

In children for the treatment of SCLC.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects.

Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
Nausea
hair loss
constipation
diarrhea
decreased appetite

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

You may report side effects to the FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at 1-888-835-2555

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.