On October 19, 2025 Pfizer Inc. (NYSE: PFE) and Astellas Pharma U.S. Inc. (Head of Commercial: Mike Petroutsas, "Astellas") reported final overall survival (OS) results from the Phase 3 EMBARK study evaluating XTANDI (enzalutamide), in combination with leuprolide and as monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For the key secondary endpoint of OS, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone (Hazard Ratio [HR]: 0.597; 95% Confidence Interval [CI], 0.444-0.804; p=0.0006), making this the first and only androgen receptor inhibitor-based regimen to demonstrate an OS benefit in nmHSPC with high-risk BCR.1 The 8-year overall survival was 78.9% (95% CI, 73.9% to 83.1%) among patients receiving XTANDI plus leuprolide and 69.5% (95% CI, 64.0% to 74.3%) among patients taking leuprolide alone.1 A numerical improvement in OS with XTANDI as monotherapy compared to leuprolide alone (HR: 0.83 [95% CI, 0.63-1.095; p=0.1867) did not reach statistical significance.1 These data are being presented today in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany and have been simultaneously published in The New England Journal of Medicine.

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"These results highlight the central role of enzalutamide in extending survival for men with conventional imaging negative HSPC with high-risk BCR," said Stephen J. Freedland, M.D., Director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai and Associate Director for Training and Education at the Samuel Oschin Comprehensive Cancer Institute. "These data reinforce the benefits of earlier treatment initiation with enzalutamide."

The median follow up time was 94.2 months for XTANDI in combination with leuprolide, 94 months for leuprolide only, and 93.8 months in the monotherapy XTANDI group.1

The safety profile of XTANDI was consistent with that observed at the primary EMBARK analysis, and no new safety signals were identified. The most common adverse events (occurring in ≥10% of patients) in the XTANDI combination group were hot flashes and fatigue. The most common adverse events in the XTANDI monotherapy group were gynecomastia, hot flashes, and fatigue.1,2

"With up to 90 percent of men with high-risk BCR developing metastatic disease, early intervention with effective therapy is critical,"3 said Johanna Bendell, M.D., Chief Development Officer, Oncology, Pfizer. "The final analysis from EMBARK shows that XTANDI plus leuprolide improved outcomes and extended lives for men facing high-risk BCR after local therapy with curative intent."

Among men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy or both, an estimated 20-40% will experience BCR within 10 years.4 About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer.3

"This marks the eighth publication of XTANDI data in The New England Journal of Medicine, further demonstrating XTANDI’s profound impact on clinical outcomes in men with certain types of advanced prostate cancer," said Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. "These findings reinforce XTANDI’s position as a cornerstone therapy in the proactive management of these patients."

The EMBARK trial primary analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus leuprolide alone (HR: 0.42 [95% CI, 0.30-0.61]; p<0.001). Additionally, MFS for XTANDI monotherapy was superior to treatment with leuprolide alone (HR: 0.63 [95% CI, 0.46-0.87]; p=0.005). Of note, the MFS for XTANDI single agent was a secondary endpoint.2

XTANDI is approved for one or more indications in more than 80 countries, including the United States, European Union, and Japan. Earlier approvals were for castration-resistant prostate cancer and metastatic castration-sensitive (hormone-sensitive) prostate cancer. It was then approved for patients with nmCSPC with BCR at high risk for metastasis in 2023 based on improved metastasis-free survival comparing the combination of enzalutamide with leuprolide vs leuprolide alone, as well as enzalutamide monotherapy vs leuprolide alone.

Descriptive updates of multiple secondary and exploratory endpoints (time to new antineoplastic therapy, time to first symptomatic skeletal events, and time to progression on subsequent therapy) were consistent with the primary analyses announced based on the MFS data cutoff in 2023.1

About EMBARK2

This Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients considered to have high-risk BCR disease had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as monotherapy, or leuprolide alone.

The primary results from the EMBARK trial were published in the New England Journal of Medicine in 2023. The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide versus leuprolide alone. MFS is defined as the duration of time between randomization and the earliest objective evidence of radiographic progression by central imaging or death.

For more information on the EMBARK (NCT02319837) trial go to www.clinicaltrials.gov.

About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

Non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.5,6 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.4 About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of the recurrence.3 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months. Patients with nmCSPC who experience BCR after local therapy may be at a higher risk of metastases and death if their PSA doubling time is ≤ 9 months.7

About XTANDI (enzalutamide)

XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally.8

About XTANDI (enzalutamide) and U.S. Important Safety Information

XTANDI (enzalutamide) is indicated for the treatment of patients with:

castration-resistant prostate cancer (CRPC)
metastatic castration-sensitive prostate cancer (mCSPC)
nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
Important Safety Information

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

(Press release, Pfizer, OCT 19, 2025, View Source [SID1234656806])

On October 19, 2025 Novartis reported new Pluvicto (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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Pluvicto plus standard of care (SoC) (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), reducing the risk of radiographic progression or death by 28% (HR 0.72; 95% CI: 0.58, 0.90) versus SoC alone in patients with prostate-specific membrane antigen (PSMA)+ metastatic hormone-sensitive prostate cancer (mHSPC)1.

Results also show an early positive trend in overall survival (OS) in patients treated with Pluvicto plus SoC (HR 0.84; 95% CI: 0.63, 1.13); follow-up will continue until data are mature1. More patients achieved a complete response versus SoC alone (57.1% vs. 42.3%) and the overall response rate (ORR) was numerically higher in the Pluvicto plus SoC arm (85.3% vs. 80.8%)1. Pluvicto delayed time to progression to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.70; 95% CI: 0.58, 0.84)1. The rPFS benefit was consistent across pre-specified subgroups1.

"In metastatic prostate cancer, choosing the most efficacious treatment early is crucial, even at initial diagnosis," said Scott T. Tagawa, MD, a professor of medicine at Weill Cornell Medicine and a medical oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. "These findings suggest that combining 177Lu-PSMA-617 with standard of care hormonal therapy offers patients more time without disease progression, a safety profile with adverse events that are most often low grade and managed with supportive care, and an encouraging trend in overall survival."

"These results reinforce the potential for Pluvicto, a radioligand therapy that delivers treatment directly to target cells, to change how we treat metastatic prostate cancer," said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. "With significant benefit now shown across multiple disease stages, Pluvicto is redefining the standard of care. The strength of these results reflects our deep commitment to patients with prostate cancer and our leadership in radioligand therapy."

The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION1,4,5. Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone1. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia1.

PSMAddition marks the third positive Phase III trial with Pluvicto1,4,5. Building on the significant benefit demonstrated in PSMAfore, which led to the US Food and Drug Administration (FDA) approval in pre-taxane mCRPC in March 2025, these new results strengthen the evidence base for Pluvicto and demonstrate its potential to improve outcomes in an even earlier stage of metastatic prostate cancer1,4,6. Novartis plans to submit these data to regulatory authorities before end of year.

About unmet need in mHSPC
Approximately 172,000 men are diagnosed with mHSPC each year across the US, China, Japan, France, Germany, Italy, Spain and the United Kingdom1. Most patients progress to mCRPC, typically within 20 months2,3,7,8. Progression to mCRPC is associated with significantly worse outcomes, including increased patient burden, worse quality of life and life expectancy less than two years9,10. More than 80% of patients with prostate cancer highly express the PSMA biomarker, making it a promising therapeutic target11-15.

About PSMAddition
PSMAddition (NCT04720157) is a Phase III, open-label, prospective, 1:1 randomized study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs. SoC alone in adult patients with PSMA+ mHSPC16. The primary endpoint is rPFS, defined as the time to radiographic progression by PCWG3-modified RECIST V1.1 (as assessed by BIRC) or death16. The key secondary endpoint of OS is defined as time to death due to any cause16. The study remains ongoing and a total of 1,144 patients with mHSPC across 20 countries have been randomized in the trial16.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)5,17. After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein5,17. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death17.

Pluvicto is the only PSMA-targeted agent approved for PSMA+ mCRPC and is the first RLT to demonstrate a clinical benefit for patients with PSMA+ mHSPC in a Phase III trial1. Novartis is investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial (NCT05939414).

(Press release, Novartis, OCT 19, 2025, View Source [SID1234656773])

On October 19, 2025 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported the first disclosure of preliminary Phase I data for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) and the Phase Ib study design for CS5001 (a ROR1-targeted Antibody-Drug Conjugate [ADC]) at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress.

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Key Highlights of CS2009 Poster Presentation:

This also represents the first known clinical data publication of a PD-1/VEGF/CTLA-4 trispecific antibody to date.

CS2009-101 is a multi-regional phase Ⅰ study currently ongoing in Australia and China. The study evaluates the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD), and antitumor activity of CS2009 in patients with advanced solid tumors.

Patients baseline characteristics:

As of the data cutoff date, 72 patients with advanced solid tumors treated across 6 dose levels (DL1-6, 1-45 mg/kg); 72.2% remain on treatment.
Heavily pretreated population: over 51% received prior immuno-oncology (IO) therapies. Median follow-up: only 1.9 months (range 0.1-6.7 months) at data cutoff.
Favorable safety and tolerability:

Dose escalation completed with no dose-limiting toxicity (DLT) reported; maximum tolerated dose (MTD) not reached.
No Grade 4 or 5 treatment-related adverse event (TRAE) observed. Incidence of Grade ≥3 TRAEs, immune-related AEs (irAEs), and VEGF-related TRAEs was 13.9%, 4.2%, and 2.8%, respectively.
Only 1 treatment-emergent adverse event (TEAE) leading to drug permanent discontinuation observed (at DL4 [20 mg/kg]; 1.4% incidence).
Promising antitumor activity and high disease control rate (DCR):

CS2009 demonstrated encouraging anti-tumor activities across tumor types. As of the cutoff date, the overall follow-up duration remained limited, particularly in higher-dose cohorts where the majority patients had yet to reach the protocol-specified time point of post-baseline tumor assessment:

49/72 patients underwent at least one post-baseline tumor assessment by data cutoff.
Despite limited follow-up duration, anti-tumor activity was observed across all dose levels with dose-dependent uptrend:
Among all 49 evaluable patients, overall response rate (ORR) was 12.2%; DCR was 71.4%. Efficacy data remains immature; with additional follow-up beyond the poster data cutoff, ORR was further improved to 14.3%.
Higher ORR (25.0%) at tentative recommended Phase 2 dose (RP2D, 30 mg/kg) and higher dose.
Promising efficacy signals were observed across multiple tumor types within the short follow-up period:
Non-Small Cell Lung Cancer (NSCLC): ORR: 11.8%, DCR: 82.4%; Post-ESMO update: stable disease (SD)-to-partial response (PR) conversion observed, ORR further elevated to 17.6%; In AGA-negative subgroup, ORR reached 25%;
Ovarian Cancer (OC): ORR: 16.7%, DCR: 66.7%;
Triple-Negative Breast Cancer (TNBC): ORR: 25.0%, DCR: 75.0%;
Non–Clear Cell Renal Cell Carcinoma (nccRCC): ORR: 33.3%, DCR: 100.0%;
Soft Tissue Sarcoma (STS): ORR: 11.1%, DCR: 66.7%.
Favorable PK and PD profiles:

Linear PK with half-life of 6-8 days supported every-three-week (Q3W) dosing, with no significant accumulation observed at cycle 3.
PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization.
Receptor occupancy of PD-1/CTLA-4 on peripheral T cells reached saturation throughout dosing interval at doses ≥20 mg/kg.
On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition.
Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals.
CStone has initiated Phase Ⅱ dose expansion study in first-line patients with selected tum or types for dose optimization and to generate data supporting registration trials in first-line NSCLC and other tumors as monotherapy or in combination therapies.

CS2009 Data Review Conference Call:

CStone will host an investor meeting to discuss presented data and future clinical development plan. The Company cordially invites all investors to attend this conference call.

Chinese-language session:

Date & Time: Monday, October 20, 2025, at 2:00 p.m. (Beijing Time)/2:00 a.m. (US Eastern Time)
Registration Link: Registration is required, please sign up via the link: View Source
English-language session:

Date & Time: Monday, October 20, 2025, at 9:00 p.m. (Beijing Time)/9:00 a.m. (US Eastern Time)
Registration Link: The Zoom meeting link will be sent to you by email after registration via the below link. You may join the meeting by clicking the link in email: View Source
Key Highlights of CS5001 ePoster Presentation:

CS5001 phase Ib study aims to determine the RP2D and further evaluate the safety, tolerability, PK, and efficacy of CS5001 as a monotherapy and in combination with systemic therapies in selected tumor types.
In monotherapy cohorts, Cohorts A-D enroll patients with chronic lymphocytic leukemia and other B-cell lymphomas, and Cohort I enrolls patients with ROR1-positive solid tumors. In combination therapy cohorts (E-H), CS5001 will be administered with standard systemic therapies (R-GemOx, R2 or R-CHOP) or with sugemalimab (an anti-PD-L1 monoclonal antibody).
Patient enrollment for CS5001 Phase Ib study commenced in December 2024 and is currently advancing smoothly at 30 sites across Australia, the United States, and China.

(Press release, CStone Pharmaceauticals, OCT 19, 2025, View Source [SID1234656791])

On October 19, 2025 Tubulis reported positive early clinical data from its NAPISTAR1-01 Phase I/IIa study (NCT06303505) in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany. Principal Investigator, Dr. Antonio González-Martín, Director Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra, presented the results of Tubulis’ lead antibody-drug conjugate (ADC), TUB-040, in platinum-resistant high-grade serous ovarian cancer (PROC-HGSOC), with a focus on dose levels 1.67 – 3.3 mg/kg. This is the first clinical data to validate Tubulis’ proprietary Tubutecan technology, establishing clear proof of concept for the company’s most advanced ADC targeting NaPi2b.

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"These positive first-in-human data for TUB-040 represent a momentous milestone for Tubulis, validating our unique ADC design strategy, and offering a potential new treatment option for patients with platinum-resistant ovarian cancer," said Dr. Dominik Schumacher, Chief Executive Officer and Co-founder of Tubulis. "Supported by our recent financing, we are poised to rapidly advance TUB-040 towards pivotal trials and expand its clinical development into earlier stages of disease and additional tumor types. The data also provides a foundation to unlock the full potential of ADCs using our Tubutecan platform, expanding its impact to benefit a significant patient population."

Highlights of Tubulis’ clinical data presented at ESMO (Free ESMO Whitepaper) 2025:

Patient population and baseline characteristics
As of the data cut-off on September 1, 2025, 67 patients (46 patients treated at dose levels of 1.67 – 3.3 mg/kg) with PROC were treated with TUB-040 for a median of 161 days (range 21–462) with 21-day treatment cycles
Median age: 62 years (range 34-81); no patient selection for biomarkers
All patients received a median of 4 prior lines of therapy (range 1-7) including bevacizumab (83.6%), PARP inhibitors (76.1%) and mirvetuximab soravtansine (13.4%)
Efficacy
In the 66 efficacy-evaluable patients who had at least one RECIST response assessment, onset of activity was observed at low doses with efficacy across a wide therapeutic range
Responses occurred early (starting at treatment cycle 2) and deepened over time and were also seen in patients who received prior mirvetuximab soravtansine treatment including when mirvetuximab soravtansine was the most recent line of therapy
Within the 1.67-3.3 mg/kg dose cohorts, an ORR of 59% (range of 50-67%), was achieved with a confirmed ORR of 50%; one complete response (CR) was observed at 2.5 mg/kg.
Treatment is ongoing in 80% of patients within the 1.67 – 3.3 mg/kg cohorts and in 93% of all responding patients from this focus group
The confirmed disease control rate (DCR) at 1.67 – 3.3 mg/kg was 96% and a confirmed DCR of 91% was reached across all cohorts at the data-cut-off with efficacy data in the 3.3 mg/kg group still continuing to mature
81% of patients within the 1.67 – 3.3 mg/kg cohorts exhibited a CA-125 response under treatment determined per GCIG standards. CA-125 is an established, prognostic and predictive tumor marker in ovarian carcinoma
Safety and tolerability
TUB-040 was generally well tolerated across all dose levels with the majority of treatment-emergent adverse events (TEAEs) at Grade 1 or 2
There were no fatal TEAE’s across all cohorts and no discontinuations due to adverse events across the 1.67 – 3.3 mg/kg cohorts
No clinically relevant bleeding, pneumonitis, ocular toxicity, stomatitis, or neuropathy were reported, distinguishing TUB-040 from other topoisomerase-I ADCs
Hematologic toxicity was predominately low-grade and manageable at doses of 1.67 – 3.3 mg/kg
Most common ≥Grade 3 TEAEs across 1.67 – 3.3 mg/kg cohorts included: neutropenia (22% ≥G3), anemia (9% ≥G3), thrombocytopenia (4% ≥G3), and nausea (4% ≥G3)
The maximum tolerated dose (MTD) was determined at 4.4 mg/kg
"The interim results demonstrated a highly differentiated clinical profile for TUB-040 in the ADC field, with anti-tumor activity beginning at low doses with a broad therapeutic window that could provide treating physicians with flexibility in dosing. They further validate NaPi2b as a clinically valuable ADC target and confirm that our Tubutecan technology can deliver exatecan for effective tumor targeting with reduced systemic toxicity," said Günter Fingerle-Rowson, MD PhD, Chief Medical Officer of Tubulis. "Our goal now is to accelerate TUB-040’s clinical development to bring this valuable drug to patients as soon as possible."

"Current treatment options for platinum-resistant ovarian cancer are constrained by low response rates, short progression-free survival, and tolerability challenges, underscoring the need for better therapies. The TUB-040 data suggest a significant advance for ADCs, since we are seeing clinical activity without the need for biomarker selection across a range of doses that were well tolerated," added Principal Investigator, Antonio González-Martín, MD PhD.

The ongoing NAPISTAR 1-01 study (NCT06303505) is evaluating TUB-040 in PROC-HGSOC and in adenocarcinoma non-small cell lung cancer (NSCLC). Based on these encouraging results, the company plans to initiate pivotal trials with TUB-040, explore earlier lines of treatment in ovarian cancer, and expand into combination regimens and new solid tumor indications. The first data from the NSCLC cohort will be presented at a future medical conference.

The full abstract will be published in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

(Press release, Tubulis, OCT 19, 2025, View Source [SID1234656807])

On October 19, 2025 Akeso (9926.HK) reported the final analysis results from the COMPASSION-15/AK104-302 study at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO 2025) . COMPASSION-15 is a Phase III clinical trial evaluating cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Professor Shen Lin, principal investigator from Peking University Cancer Hospital, presented the findings in an oral session at ESMO (Free ESMO Whitepaper) 2025.

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In this final analysis presented at ESMO (Free ESMO Whitepaper) 2025 (median follow-up: 33.9 months), the cadonilimab regimen demonstrated enhanced long-term survival benefits in first-line advanced G/GEJ adenocarcinoma. With the extended follow-up period and more mature data, the cadonilimab treatment regimen showed a further reduction in the risk of death compared to the control group. This consistent benefit was observed across all PD-L1 expression subgroups.

The interim analysis of COMPASSION-15, with a median follow-up of 18.7 months, was previously published in Nature Medicine in January 2025. The data presented at ESMO (Free ESMO Whitepaper) 2025 were analyzed using the same statistical methodology.

COMPASSION-15 2025 ESMO (Free ESMO Whitepaper) Data

In the intent-to-treat (ITT) population:

With long-term follow-up, the cadonilimab regimen demonstrated a significant 39% reduction in the risk of death (OS HR 0.61) versus the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.66).
With extended follow-up, in the PD-L1 CPS ≥5 population, the cadonilimab regimen demonstrated a significant 51% reduction in the risk of death (OS HR 0.49; p < 0.001) compared to the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.58).
With long-term follow-up, in the PD-L1 CPS <5 population, the cadonilimab regimen showed a significant 24% reduction in the risk of death (OS HR 0.76; 95% CI: 0.59-0.99; p = 0.019) versus the control group, with a strengthening trend of benefit compared to the data from the median 18.7-month follow-up (OS HR 0.75; 95% CI: 0.56-1.00).
Following extended the follow-up period, the cadonilimab combination regimen maintained a favorable safety profile, with no new safety signals emerging.
In the COMPASSION-15 study, patients with PD-L1 CPS <5 (low expression) and CPS <1 (negative expression) are 49.8% and 23%, respectively, of the ITT population. This represents a higher proportion of PD-L1 low and negative patient population in COMPASSION-15 compared to previous Phase III trials of other immune checkpoint inhibitors used in the treatment of first-line gastric cancer. Previous studies have shown limited responses to PD-1/L1 inhibitors in PD-L1 low-expression or negative patients.

Cadonilimab was approved by the NMPA in September 2024 for the first-line treatment for advanced gastric cancer, offering a new and effective immunotherapy option. Cadonilimab has been included in the 2025 CSCO Gastric Cancer Guidelines as the only Category I recommendation (Level 1A evidence) for first-line immunotherapy, regardless of PD-L1 expression, and is currently widely used in clinical practice.

(Press release, Akeso Biopharma, OCT 19, 2025, View Source [SID1234656792])