On October 20, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the third quarter ended September 30, 2025.

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Planned BLA Submission for Ivonescimab in Q4 2025

Today, Summit announces that, based on the results of the HARMONi clinical trial, it plans to submit a Biologics License Application (BLA) in order to seek approval for ivonescimab plus chemotherapy for this proposed indication. We intend to submit the BLA in the fourth quarter of 2025. The positive results of the multiregional Phase III study are detailed further below. As previously noted, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting. After careful consideration of the safety and efficacy profile of the current FDA-approved options for patients in this setting, the positive results of the Phase III multiregional study, including regional consistency, as well as discussions with key opinion leaders and those physicians who have administered ivonescimab to patients in a clinical study setting, we believe that the safety and efficacy data generated in the HARMONi study demonstrates that patients suffering from epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) in this setting can benefit from the ivonescimab regimen despite the lack of a statistically significant showing on overall survival.

Further Expansion of the Phase III Ivonescimab Clinical Development Program

In addition to the announcement HARMONi-GI3, a new global Phase III study in first-line unresectable metastatic colorectal cancer (CRC), Summit today announces its intention to expand its ivonescimab clinical development program with an additional set of Phase III clinical studies. We intend to provide additional color with respect to these Phase III studies in the first quarter of 2026.

Other Operational & Corporate Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

Since in-licensing ivonescimab (SMT112), from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023, over 3,000 patients have been treated with ivonescimab in clinical studies globally, and over 40,000 patients when considering those treated in a commercial setting in China as noted by Akeso. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.
Summit is developing ivonescimab in NSCLC, specifically conducting Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression
In addition, Summit plans to start developing ivonescimab in CRC with an intention to begin a Phase III clinical study in the following proposed indication:
HARMONi-GI3: ivonescimab combined with chemotherapy in patients with first-line metastatic CRC
In September 2025, we announced detailed results from our multiregional, double-blinded, placebo-controlled, Phase III study, HARMONi, including data from the study’s prespecified primary analysis as well as results from longer-term follow up in western patients.
At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS), the magnitude of which we believe to be clinically meaningful, with a hazard ratio (HR) of 0.52 (95% CI: 0.41 – 0.66; p<0.00001); median PFS was 6.8 months for those patients receiving ivonescimab plus chemotherapy compared to 4.4 months for those receiving chemotherapy. In a longer-term follow-up of PFS, which included all western patients, ivonescimab plus chemotherapy demonstrated a consistent improvement in PFS with an observed HR of 0.57 (95% CI: 0.46 – 0.71). We believe the PFS HR that was observed in both Asian and western sub-populations to be clinically meaningful. In both the primary analysis as well as longer-term follow-up analysis, consistency of the magnitude of PFS benefit was demonstrated between patients randomized in Asia and ex-Asia. PFS was assessed by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. The longer-term follow-up analysis of PFS was performed at the time of the primary overall survival (OS) analysis.
In the prespecified primary analysis, a positive trend in OS was observed without achieving a statistically significant benefit with an HR of 0.79 (95% CI: 0.62 – 1.01; p=0.057). Median OS was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. Analysis from longer-term follow-up in western patients, resulted in an OS HR consistent with the primary analysis with an improved nominal p-value (HR=0.78; 95% CI: 0.62 – 0.98; nominal p=0.0332). Median OS in the longer-term follow-up analysis remained the same in both arms from the primary analysis, 17.0 months in western patients receiving ivonescimab compared to 14.0 months for those receiving placebo (HR=0.84). Median OS in North American patients, specifically, had not yet been reached in the ivonescimab arm compared to 14.0 months in the placebo arm (HR=0.70). The HRs for western patients in totality, as well as patients from the North American and European regions individually, improved from the primary OS analysis to the analysis with longer-term follow-up of western patients. Consistent benefit was observed across pre-defined subgroups, with both Asian and North American patients demonstrating a positive trend in OS.
These trends provide further support for ivonescimab’s use in 2L+ EGFRm NSCLC, a setting where high unmet need continues to exist with limited approved options in the United States and other western territories. Currently there are no FDA-approved regimens that have demonstrated a statistically significant OS benefit in this patient setting. The results of the primary and longer-term follow up analysis in this multiregional study were consistent with that of the single-region HARMONi-A study, which demonstrated an OS HR of 0.80 at 52% data maturity in a similar patient population.
The dual primary endpoints were allocated separate alpha levels and tested individually. The alpha was recycled from the PFS to the OS analysis upon the successful achievement of the PFS endpoint.
Observed overall response rates (ORR) were 45% in the ivonescimab arm vs. 34% in the placebo arm; median duration of response (DoR) was longer in those patients administered ivonescimab plus chemotherapy (7.6 months) compared to those receiving placebo and chemotherapy (4.2 months).
The safety profile of ivonescimab in combination with chemotherapy was acceptable and manageable in the context of the observed clinical benefit, with comparable rates of discontinuation and death between both arms. There were 16 patients (7.3%) who discontinued ivonescimab due to treatment-related adverse events (TRAEs) compared to 11 patients (5.0%) who discontinued placebo due to TRAEs. There were four patients (1.8%) in the ivonescimab plus chemotherapy arm and five patients (2.3%) in the chemotherapy alone arm who died as a result of TRAEs. In the ivonescimab plus chemotherapy arm, 50.0% of patients experienced Grade 3 or higher TRAEs compared to 42.2% in the chemotherapy arm. Of note, 0.9% of patients in the ivonescimab plus chemotherapy arm experienced Grade 3 or higher hemorrhage (bleeding) events.
Last week, we announced the expansion of our Phase III clinical development program into CRC with the planned initiation of the global Phase III HARMONi-GI3 trial. The trial will evaluate ivonescimab plus chemotherapy compared to bevacizumab plus chemotherapy as first line therapy in patients with unresectable metastatic CRC. Clinical trial sites for HARMONi-GI3 are planned to begin activating in the United States prior to the end of the year. The study intends to enroll 600 patients in this multiregional study. The primary endpoint for this study is PFS.
Each year, approximately 48,000 patients are estimated to be diagnosed with or have unresectable recurrent metastatic microsatellite stable (MSS) CRC (also known as mismatch repair-proficient colorectal cancer, or pMMR CRC). There have been limited options approved in the United States in the last 20 years for those first-line patients whose tumors are not positive for certain biomarkers or other activating mutations. MSS CRC is a setting where monoclonal PD-1 inhibitors such as pembrolizumab and nivolumab have failed to show a clinically meaningful benefit. Anti-VEGF therapy (e.g., bevacizumab) plus chemotherapy is the standard of care for many patients with first-line metastatic MSS CRC.
In April 2025, Akeso announced that HARMONi-6, which evaluated ivonescimab combined with platinum-based chemotherapy vs. tislelizumab, a PD-1 inhibitor, with the same chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression, met its primary endpoint of PFS. Yesterday, additional HARMONi-6 data were presented as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) and featured in a manuscript published in The Lancet simultaneously. The presentation and publication are based on the results of HARMONi-6, a single region, multi-center, Phase III study conducted in China sponsored by Akeso, Inc., with data generated and analyzed by Akeso.
In the HARMONi-6 planned interim analysis of progression-free survival (PFS), ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint, PFS, by Independent Radiologic Review Committee (IRRC), when compared to tislelizumab in combination with chemotherapy, achieving a hazard ratio (HR) of 0.60 (95% CI: 0.46, 0.78; p<0.0001). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression.
Both the overall response rate (ORR) measured according to RECIST v1.1 criteria, as well as the duration of response (DoR) were higher in patients treated with ivonescimab plus chemotherapy compared to those treated with tislelizumab plus chemotherapy.
Ivonescimab demonstrated an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies conducted studying ivonescimab. In squamous NSCLC, VEGF-A monoclonal antibodies have not been approved by health authorities including the FDA and have had limited clinical development based on historical early phase clinical trials, primarily due to significant risks of toxicity, including hemorrhage and other life-threatening, bleeding-related complications. The results of this study further validate the unique mechanism of action of ivonescimab, including key differences as compared to separately administering an anti-PD-1 monoclonal antibody and an anti-VEGF monoclonal antibody.
In this Phase III study, there were nine patients (3.4%) who discontinued ivonescimab plus chemotherapy due to treatment-related adverse events (TRAEs) compared to 11 patients (4.2%) who discontinued tislelizumab plus chemotherapy due to TRAEs. There were eight patients (3.0%) in the ivonescimab plus chemotherapy arm and 10 patients (3.8%) in the tislelizumab plus chemotherapy arm who died as a result of TRAEs in this Phase III study. The most frequent TRAEs for ivonescimab treatment in combination with chemotherapy were common chemotherapy-related AEs, including alopecia, anemia, and various laboratory abnormalities, including neutrophil, white blood cell, and platelet count decreases. Grade 3 or higher immune-related adverse events occurred in 9.0% of patients receiving ivonescimab in combination with chemotherapy and 10.2% of patients receiving tislelizumab in combination with chemotherapy. Grade 3 or higher adverse events that were possibly VEGF-related in the ivonescimab plus chemotherapy arm were 7.5% vs. 2.3% for tislelizumab plus chemotherapy. Most of the possibly VEGF-related adverse events occurring in the ivonescimab plus chemotherapy arm were classified as Grade 1 or 2. Of note, Grade 3 or higher hemorrhage events were observed in five patients in the ivonescimab plus chemotherapy arm compared to two patients in the tislelizumab plus chemotherapy arm in this study.
This marks the first known Phase III trial in NSCLC to show significant improvement over PD-(L)1 inhibitor therapy combined with chemotherapy in a head-to-head setting. Following the success of Akeso’s HARMONi-2 study in China, this is the second instance where ivonescimab-based regimens have demonstrated a statistically significant benefit compared to standard-of-care PD-(L)1 inhibitor-based regimens in a Phase III trial.
Yesterday, we announced an update to our HARMONi-3 Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab, a PD-1 inhibitor, combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. The primary endpoints for this study are PFS and OS.
Summit has amended the protocol for the HARMONi-3 study in order to separate the statistical analysis (i.e., the outcome) of the primary endpoints by histology. Therefore, there will be separate analyses conducted to evaluate ivonescimab plus chemotherapy compared to pembrolizumab plus chemotherapy in patients with squamous NSCLC and in patients with non-squamous NSCLC.
As a result of having two separate intention-to-treat analyses within the HARMONi-3 study, the analyses for squamous tumors and non-squamous tumors may be conducted at separate times, as each analysis will be conducted upon the prespecified numbers of events being reached in the separate cohorts.
Summit currently expects to complete enrollment in the squamous cohort of HARMONi-3 in the first half of 2026 and expects to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the second half of 2026. An interim analysis for overall survival may be conducted at a similar time.
At present time, Summit expects to complete enrollment in the non-squamous cohort of HARMONi-3 in the second half of 2026 and expects to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the first half of 2027. An interim analysis for overall survival is planned to be conducted based upon reaching a prespecified number of events.
In order to sufficiently power each of the dual primary endpoints in both cohorts of this study, Summit plans to enroll 600 patients with squamous NSCLC and 1,000 patients with non-squamous NSCLC.
Clinical trial collaborations and investigator sponsored trials with leading organizations, including MD Anderson, the Memorial Sloan Kettering Cancer Center, and the Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumor settings outside of metastatic NSCLC.
In June 2025, we announced a clinical collaboration with Revolution Medicines to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. We expect that clinical trials associated with this collaboration will begin in early 2026.
Enrollment continues in Summit’s global Phase III trials, HARMONi-3 and HARMONi-7. In addition to the enrollment in multiregional studies conducted and sponsored by Summit, our partners at Akeso are also enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, colorectal cancer, and pancreatic cancer.
Financial Highlights

Cash and Cash Equivalents and Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $238.6 million and $412.3 million at September 30, 2025 and December 31, 2024, respectively.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $234.2 million for the third quarter of 2025, compared to $58.4 million for the same period of the prior year. The increase in GAAP operating expenses was due to the increase in stock-based compensation expense of $111.4 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.
Non-GAAP operating expenses were $103.4 million for the third quarter of 2025, compared to $39.0 million for the same period of the prior year. The increase in Non-GAAP operating expenses due to expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses were $131.1 million for the third quarter of 2025, compared to $37.7 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $34.8 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.
Non-GAAP R&D expenses were $90.5 million for the third quarter of 2025, compared to $31.9 million for the same period of the prior year. The increase is primarily related due to expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $103.1 million for the third quarter of 2025, compared to $20.7 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $76.6 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.
Non-GAAP G&A expenses were $12.9 million for the third quarter of 2025, compared to $7.1 million for the same period of the prior year. The increase is related to building our infrastructure to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss

GAAP net loss in the third quarter of 2025 and 2024 was $231.8 million or $(0.31) per basic and diluted share, and $56.3 million or $(0.08) per basic and diluted share, respectively.
Non-GAAP net loss in the third quarter of 2025 and 2024 was $101.0 million or $(0.13) per basic and diluted share, and $36.9 million or $(0.05) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures

This release includes measures that are not in accordance with U.S. generally accepted accounting principles ("Non-GAAP measures"). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.

About Ivonescimab

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

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al., SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al., SITC (Free SITC Whitepaper), 2023) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 3,000 patients have been treated with ivonescimab in clinical studies globally, and over 40,000 treated in a commercial setting in China as noted by Akeso.

Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In early 2025, the Company began enrolling patients in the United States for HARMONi-7. Summit intends to open clinical trial sites in the United States for the Phase III study in CRC by the end of 2025.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results were announced in May of 2025, with detailed results provided in September 2025.

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

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

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

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6.

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

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

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

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

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

(Press release, Summit Therapeutics, OCT 20, 2025, View Source [SID1234656845])

On October 20, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.

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The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001).

This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.1,2

These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade ≥3 toxicity related to immunotherapy.

Dr. Katarzyna Kozak, said: "The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial’s primary endpoint in resectable soft tissue sarcoma. These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti’s unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas. We hope these findings can help pave a path to a new therapeutic option for the substantial unmet medical need in this challenging indication."

Marc Voigt, CEO of Immutep, noted: "We sincerely thank the principal investigators leading this study, as well as the patients and their families for taking part in this important trial. There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy."

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3

The EFTISARC-NEO study has been primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

The presentation slides can be found on the Posters & Publications page of Immutep’s website.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, OCT 20, 2025, View Source [SID1234656867])

On October 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer. The findings are being presented in BriaCell’s poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 Annual Meeting taking place October 17 – 21, 2025 in Berlin, Germany. The Phase 3 data shown is for all patients evaluated regardless of treatment assignment (i.e. is blinded).

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"We are encouraged by the early constructive clinical biomarker data which could allow us to predict clinical and survival outcomes in our patients and would help guide treatment decisions for metastatic breast cancer patients with limited options," stated Dr. William V. Williams, BriaCell’s President and CEO.

Poster #3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)

In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Treatment of Physician’s Choice, or Bria-IMT monotherapy. As of the time of the poster submission, pooled data was available in 113 patients, with a median of 6 prior lines of treatment (2–13). Evaluable only pertains to imaging. All 113 are evaluated for safety, PFS, etc.

As reported in the Phase 2 study , Neutrophil to Lymphocyte Ratio (NLR) continues to be a potential biomarker of clinical benefit as progression free survival (PFS) was significantly higher in patients with NLR of 0.7 – 2.3 (4.5 months) vs those with NLR < 0.7 or > 2.3 (2.5 months) {(HR) of 0.5 (95% CI 0.3–0.8, p=0.005)}.

In the Phase 3 study, PFS data comparing BriaCell’s Bria-IMT combination regimen versus those treated with physician’s choice remains blinded at this time. Bria-IMT has been well tolerated in the Phase 3 study with no treatment-related discontinuations due to adverse events (AEs). The most common AEs are minor, including fatigue, anemia, and nausea.

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

A copy of the poster presentation is posted on View Source

(Press release, BriaCell Therapeutics, OCT 20, 2025, View Source [SID1234656936])

On October 20, 2025 Alphamab Oncology (stock code: 9966.HK) reported that two latest clinical data on biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 for the treatment of primary platinum-refractory ovarian cancer (OC) and HER2-positive metastatic colorectal cancer (mCRC), along with the confirmatory study design of the phase III study of JSKN003 versus physician’s choice of chemotherapy in platinum-resistant ovarian cancer (PROC) were presented as posters at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025) from October 17 to 21, 2025, in Berlin, Germany (Press release, Alphamab, OCT 20, 2025, View Source [SID1234656988]).

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Title: Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC)
Presentation Number: 1079P
Onsite Poster display date: Saturday, 18 October 2025
First author: Xiaohua Wu, Fudan University Shanghai Cancer Center
Speaker: Jiajia Li, Fudan University Shanghai Cancer Center

METHODS

Therapies represented by ADCs have made certain progress in treating platinum-resistant ovarian cancer (PROC), but not for primary platinum-refractory disease (defined as disease that progressed within 3 months after the last dose of first-line platinum-containing therapy) that were excluded from most of trials. Novel therapeutic options are urgently needed for this patient population with poorer prognosis compared to those who are not primary platinum-refractory. JSKN003-102 (NCT05744427) is a phase I/II trial conducted in China, enrolling patients with advanced solid tumors to receive JSKN003 monotherapy. The findings of JSKN003 in treating patients with primary platinum-refractory OC were reported at this ESMO (Free ESMO Whitepaper) Congress.

RESULTS

As of June 13, 2025, a total of 26 patients with primary platinum-refractory OC were enrolled and received JSKN003 at 6.3 mg/kg every three weeks. The median age was 54 years, with 80.8% of them having ECOG PS 1. Among the patients, 15 patients were HER2-negative (IHC 0), 8 had HER2 expression (IHC 1+/2+/3+), with only one being IHC 3+), and 3 patients had no tumor sample available for assessment. All patients had prior treatments, of whom 84.6% had previously been treated with bevacizumab, 26.9% had received PARP inhibitors, and 57.7% had undergone two or more lines of systemic anti-tumor therapies. Additionally, 38.5% of the patients had liver metastases, while 26.9% had lung metastases.

Efficacy: As of June 13, 2025, 25 patients were efficacy evaluable. The overall response rate (ORR) was 32.0%, the disease control rate (DCR) was 72.0%, the median progression-free survival (PFS) was 4.1 months, and the 9-month overall survival (OS) rate was 65.4%. Efficacy was observed across different HER2 expression subgroups.

Safety: Grade 3 or above treatment related adverse events (TRAE) occurred in 15.4% of patients. Serious TRAEs were reported in 1 patient (3.8%). No TRAE led to death. Interstitial lung disease (ILD) was observed in 2 patients and both were Grade 1.

CONCLUSIONS

JSKN003 demonstrated promising efficacy and tolerability in patients with primary platinum-refractory OC who have limited treatment options. Efficacy was observed across different HER2 expression subgroups, offering new hope for this patient population.

Title: Efficacy and Safety of JSKN003, a Biparatopic anti-HER2 Antibody Drug Conjugate (ADC), in Patients with HER2-positive Metastatic Colorectal Cancer (mCRC)
Presentation Number: 806P
Onsite Poster display date: Sunday, 19 October 2025
First author & Speaker: Dan Liu, Peking University Cancer Hospital and Institute

METHODS

JSKN003-102 (NCT05744427) is a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in Chinese patients with advanced/metastatic solid tumors. The efficacy and safety data of JSKN003 in HER2-positive (IHC 3+ or 2+/FISH+) mCRC patients were reported at this ESMO (Free ESMO Whitepaper) Congress.

RESULTS

As of June 30, 2025, a total of 33 patients with HER2-positive mCRC were enrolled and received JSKN003 every three weeks across 2 dose levels, among which 32 patients at the dose 6.3 mg/kg and 1 patient at the dose of 8.4 mg/kg. 69.7% of enrolled patients were male with a median age of 59 (range, 30-69). All enrolled patients were stage IV at screening and 54.5% with liver metastases. 5 (15.2%) patients harbored RAS/RAF mutations, including 1 case of BRAF V600E mutation. All patients were heavily pretreated, and 42.4% had received three or more lines of prior anti-tumor treatments.

Efficacy: 32 patients were efficacy evaluable. The ORR was 68.8%, the DCR was 96.9%. Additionally, among 31 BRAF V600E wild-type patients, the ORR was 71.0%, the DCR was 100%, and median duration of response (DoR) was 9.89 months (95%CI, 5.78 to NE), the median PFS achieved 11.04 months (95%CI, 6.9 to 14.03), with a 9-month PFS rate of 66.6%.

Safety: The median follow-up time was 9.26 months (95%CI: 5.82, 12.35). 7 patients (21.2%) experienced Grade 3 or above TRAEs. There were no TRAEs led to discontinuation or death. Overall, the most common TRAEs were diarrhea and nausea, most of which were Grade 1-2. ILD was reported in 4 patients (12.1%), which were Grade 1-2.

CONCLUSIONS

JSKN003 demonstrated promising efficacy in heavily pretreated HER2-positive CRC with a manageable and predictable safety profile. The biparatopic HER2 antibody design may enhance target binding and contribute to the observed clinical benefit.

Title: Phase III study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician’s choice of chemotherapy in platinum-resistant ovarian cancer (PROC): JSKN003-306
Presentation Number: 1219TiP
Onsite Poster display date: Saturday, 18 October 2025
First author & Speaker: Lingying Wu, Cancer Hospital Chinese Academy of Medical Sciences

BACKGROUND

Platinum-resistant ovarian cancer (PROC) is known for low efficacy to non-platinum single-agent chemotherapy with or without bevacizumab, the standard-of-care (SOC), with an ORR of 15%, a PFS of 3 months, and an OS of 12 months, posing a significant therapeutic challenge.

Results from the Phase I clinical study JSKN003-101 (NCT05494918) in Australia and the Phase I/II clinical study JSKN003-102 (NCT05744427) in China have demonstrated promising efficacy of JSKN003 monotherapy in PROC. Detailed data were presented at the 2024 ESMO (Free ESMO Whitepaper) Congress for the first time and subsequently updated at the 2025 Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). As of February 28, 2025, 46 PROC patients were enrolled and received JSKN003 every three weeks. In 46 efficacy-evaluable patients, 45.7% were HER2 no-expressing (IHC 0). 91.3% of patients exhibited tumor shrinkage, the ORR was 63.0%, the median PFS was 7.7 months and the 9-month OS rate was 89.9%. In HER2 expressing (IHC 1+/2+/3+) patients, the ORR and median PFS were 72.2% and 9.4 months, respectively.

Based on the pooled analysis of the two clinical studies, JSKN003 monotherapy has been granted breakthrough therapy designation for the treatment of PROC by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). So far, JSKN003 is the only anti-HER2 ADC to receive this designation without HER2 expression restrictions.

STUDY DESIGN

JSKN003-306 (NCT06751485) is randomized, open-label, parallel-controlled, multi-center Phase III clinical study, enrolling patients with recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer, irrespective of HER2 expression. Key inclusion criteria include: age≥18 years; having received 1 to 4 prior lines of systemic anti-tumor therapy; disease progression within 6 months after the last dose of platinum-base chemotherapy; an ECOG PS of 0-1; adequate organ function; and measurable disease by RECIST v1.1. Key exclusion criteria include: prior TOPli or TOPli-containing ADC; active central nervous system metastases; interstitial lung disease (ILD); or uncontrollable comorbidities.

Patients will be randomized 1:1 and stratified by platinum-free interval (≤3 months vs. 3 to 6 months), number of prior lines of therapy (1/2 lines vs. 3/4 lines), and HER2 status (expressing vs. non-expressing) as assessed by a central laboratory. The experimental group will receive JSKN003 at 6.3 mg/kg once every 3 weeks, while the control group will receive the investigator’s choice of chemotherapy (paclitaxel, liposomal doxorubicin, or topotecan). The primary endpoints are PFS by blind independent central review (BICR) as per RECIST v1.1 and OS. Secondary endpoints include other efficacy outcomes assessed by BICR (ORR, DoR, DCR), investigator-assessed efficacy endpoints, safety, and others.

The JSKN003-306 study plans to enroll 556 patients across 80 sites in China. The first patient was successfully dosed in February 2025, and the study is currently in the patient enrollment phase. This study aims to further validate the superiority of JSKN003 over current therapies, potentially representing a breakthrough in treating PROC.

About JSKN003

JSKN003 is Alphamab Oncology’s first bispecific ADC, developed based on HER2-targeting bsAb KN026, and utilizing the proprietary glycan-specific conjugation platform. It binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, exerting anti-tumor effects. Compared to similar ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window.

Clinical data in heavily pretreated advanced solid tumors have shown high-security profile, with promising efficacy of JSKN003, particularly in platinum-resistant ovarian cancer (PROC), HER2-high/low breast cancer (BC), HER2-positive colorectal cancer (CRC)/ gastric cancer (GC) and other HER2-expressing tumors. JSKN003 was granted breakthrough therapy designation by CDE for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and HER2-positive advanced colorectal cancer that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for GC and gastroesophageal junction cancer (GEJ). Three Phase III trials in HER2-low expressing BC, PROC, and HER2-positive BC and multiple Phase II studies are underway.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK). JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003.

On October 20, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported detailed results from STELLAR-303, a global phase 3 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq) versus regorafenib in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC). As previously announced, the study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the intention-to-treat (ITT) population at the final analysis (stratified hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.69-0.93; P=0.0045). At a median follow-up of 18.0 months, median overall survival (OS) in the ITT population was 10.9 months with zanzalintinib in combination with atezolizumab versus 9.4 months with regorafenib. Detailed findings from the study, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases, are being presented today at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress during the Proffered Paper Session 2: GI Tumours, Lower Digestive at 9:25 a.m. CEST and simultaneously published in The Lancet.

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"While treating non-MSI-high metastatic colorectal cancer remains a challenge, the combination of zanzalintinib and atezolizumab has shown consistent benefits across key subgroups of patients," said Anwaar Saeed, M.D., Section Chief of Gastrointestinal Oncology at the University of Pittsburgh, Director of the Gastrointestinal Disease Center at UPMC Hillman Cancer Center and a lead investigator of the trial. "STELLAR-303 is the first immunotherapy-based phase 3 trial that demonstrated improved overall survival with a differentiated kinase inhibitor compared to a standard of care in this patient population. The survival benefit was demonstrated early and was consistent throughout the trial, underscoring the combination’s potential for patients in need of a new and effective treatment option after disease progression."

An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy, as presented in Table 1 below. The 12- and 24-month landmark OS estimates were 46% (95% CI: 41-51) and 20% (95% CI: 15-26), respectively, for the combination of zanzalintinib and atezolizumab, and 38% (95% CI: 34-43) and 10% (95% CI: 6-16), respectively, for regorafenib.

TABLE 1

Median OS, months (95% CI)

HR (95% CI)

Zanzalintinib + Atezolizumab

Regorafenib

Geographic region

Asia

11.5 (9.2-13.7)

8.8 (7.8-10.4)

0.77 (0.59-1.00)

Rest of the world

10.9 (9.3-12.3)

9.8 (8.3-10.9)

0.82 (0.68-0.99)

RAS status

Wild type

12.0 (10.1-14.6)

10.4 (8.7-12.3)

0.79 (0.61-1.01)

Mutant

10.3 (9.0-11.9)

8.7 (8.1-9.8)

0.80 (0.66-0.98)

Active liver metastases

Presence

8.9 (8.0-9.9)

7.7 (6.5-8.5)

0.78 (0.65-0.94)

Absence

15.9 (13.5-17.6)

12.8 (10.9-15.5)

0.77 (0.59-1.01)

Prior anti-VEGF antibody treatment

Yes

10.6 (9.3-12.5)

8.8 (8.3-9.9)

0.80 (0.68-0.95)

No

11.5 (8.7-13.5)

11.1 (9.5-12.6)

0.80 (0.56-1.15)

OS = overall survival; CI = confidence interval; HR = hazard ratio; VEGF = vascular endothelial growth factor

Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases, NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination (15.9 months versus 12.8 months; stratified HR: 0.79; 95% CI: 0.61-1.03; P=0.0875) at a median follow-up of 16.8 months. The trial will proceed to the planned final analysis for this endpoint.

"These detailed results from STELLAR-303 provide further insight into the combination of zanzalintinib and atezolizumab as a potential new option to extend survival in patients with previously treated metastatic colorectal cancer," said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. "Before the end of this year, we intend to complete the submission of our first new drug application for zanzalintinib as we work toward bringing this combination regimen to a patient community seeking a new and chemotherapy-free option. These data, along with our robust clinical trial program, underscore the progress we are making toward our goal of increasing the scope and scale of the solid tumor types zanzalintinib may help address."

A trend for improvement in PFS with the combination was also observed in the ITT population (stratified HR: 0.68 [95% CI: 0.59–0.79]; median, 3.7 [95% CI: 3.5–3.8] months versus 2.0 [95% CI: 1.9–2.6] months), though statistical superiority cannot be claimed at this time due to the prespecified hierarchical testing strategy. The trend for PFS improvement with zanzalintinib in combination with atezolizumab versus regorafenib was consistent across subgroups.

The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Grade 3/4 treatment-related adverse events (AEs) occurred in 59% of patients receiving zanzalintinib in combination with atezolizumab and 37% of patients receiving regorafenib. AEs leading to discontinuation of all study treatment occurred in 18% versus 15% of patients, respectively. The most common grade 3/4 treatment-related AEs were hypertension (15% versus 9%, respectively), fatigue (6% versus 2%), diarrhea (6% versus 2%) and proteinuria (6% versus 2%). Deaths considered related to treatment by investigators were two for zanzalintinib, two for atezolizumab, one for the combination and one for regorafenib.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, OCT 20, 2025, View Source [SID1234656814])