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Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment

On October 19, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Meeting. The data demonstrated a progression-free survival (PFS) benefit for patients who experienced disease progression while on or after taking a PARP inhibitor (PARPi), a patient population with particularly poor prognosis. The presentation slides can be found here. The company also announced expansion of the Phase 2 BELLA trial in a poster session at ESMO (Free ESMO Whitepaper), found here.

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New relacorilant data presented at ESMO (Free ESMO Whitepaper) demonstrated a consistent benefit in PARPi subgroups to overcome chemotherapy resistance. Relacorilant plus nab-paclitaxel showed a PFS benefit in patients with prior PARPi treatment (hazard ratio: 0.60; p-value: 0.0035) and in patients whose disease progressed while on a PARPi (hazard ratio: 0.56; p-value: 0.0046), with a median PFS of 7.36 months for both subgroups. Relacorilant plus nab-paclitaxel was well-tolerated in the PARPi subgroups, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

"These new ROSELLA data substantiate the significant benefit of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, an extremely difficult-to-treat cancer," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, European Network of Gynaecological Oncological Trial groups Principal Investigator in the ROSELLA trial and ESMO (Free ESMO Whitepaper) presenter. "These findings are especially promising for patients with an exceptionally poor prognosis and necessitate further research of relacorilant and its potential benefit in earlier treatment lines of gynecological cancers."

Corcept also announced the expansion of the recently initiated Phase 2 BELLA trial to three study arms to evaluate the efficacy and safety of: (i) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-resistant ovarian cancer; (ii) relacorilant plus nab-paclitaxel and bevacizumab to treat patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARPi and (iii) relacorilant plus nab-paclitaxel to treat patients with endometrial cancer who had received one or two prior lines of therapy. Initial results are expected in late 2026.

"The ROSELLA data give us confidence to expand the BELLA trial to include patients with ovarian cancer whose disease is platinum sensitive (an earlier stage of tumor progression), as well as patients with endometrial cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "With the FDA’s recent acceptance of our New Drug Application for relacorilant in platinum-resistant ovarian cancer and the expansion of our BELLA trial, we are closer than ever to bringing new and vital treatment to patients in need. We are grateful to all the patients and investigators for participating in our ongoing trials."

Corcept previously announced that ROSELLA met its primary endpoint of improved PFS, with no need for biomarker selection. Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in the risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). An interim analysis of overall survival (OS) showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients’ lives (hazard ratio: 0.69; p-value: 0.0121).

The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns six months after receiving platinum-containing therapy have "platinum-sensitive" disease and those with disease progression of less than six months have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease and 13,000 women with platinum-sensitive disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

(Press release, Corcept Therapeutics, OCT 19, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-esmo-2025-late-breaker-relacorilant [SID1234656765])

Research Updates on a Phase III Clinical Trial of Anbenitamab (KN026) Presented at ESMO Congress 2025 LBA Oral Presentation Session

On October 18, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the first interim analysis results of a phase III clinical trial of anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), in combination with chemotherapy as second-line or above treatment of HER2-positive gastric cancer (GC) (including gastroesophageal junction cancer (GEJ)) (Study ID: KN026-001, also known as KC-WISE), have been presented at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025) Late-Breaking Abstract (LBA) Oral Presentation Session.

LBA Oral Presentation Session is a highly anticipated global highlight of the ESMO (Free ESMO Whitepaper) Congress. The research presented in this category is both highly topical and of significant clinical value. Their findings often herald potential impacts on current clinical practice and can even guide the future direction of entire therapeutic fields.

Title：KN026 in combination with chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE

Number: LBA 78

Speaker: Jianming Xu, Chinese PLA General Hospital

Date：Friday, 17 October 2025

METHODS

Enrolled patients in study KN026-001 (KC-WISE) with HER2-positive GC/GEJ who had disease progression after trastuzumab-based therapy were randomized to receive either anbenitamab (KN026) in combination with chemotherapy (the "Anbenitamab Group") or chemotherapy with placebo (the "Control Group"). The patients were stratified based on (i) type of chemotherapy, (ii) HER2 expression level, and (iii) number of prior lines of treatments.

RESULTS

At baseline, patient characteristics were generally well balanced between the two groups. The median age was approximately 64 in the Anbenitamab Group and 61 in the Control Group. In both groups, over 80% of patients had an ECOG PS of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment. All patients had previously received chemotherapy, most commonly taxanes (over 70%), with the remainder receiving irinotecan-based regimens.

As of April 3, 2025, the median follow-up duration was 9.7 months (95% CI, 7.2 to 11.9 months) in the Anbenitamab Group and 9.8 months (95% CI, 7.4 to 12.9 months) in the Control Group.

Efficacy as assessed by the Independent Review Committee (IRC):

● The median treatment-related adverse event (PFS) for the Anbenitamab Group was 7.1 months, compared with 2.7 months in the Control Group. The hazard ratio (HR) is 0.25 (P value is 5.44 × 10⁻¹²), corresponding to a 75% reduction in the risk of disease progression or death.

● The median overall survival (OS) for the Anbenitamab Group was 19.6 months (not mature), compared with 11.5 months in the Control Group. The HR is 0.29, representing a 71% reduction in the risk of death, and P value is 1.56 × 10⁻6, which is well below the prespecified extremely stringent alpha threshold of 0.00001.

● The objective response rate (ORR) was 55.8% in the Anbenitamab Group versus 10.8% in the Control Group, while the disease control rate (DCR) was 80.0% and 41.9%, respectively. The median duration of response (DoR) was 8.2 months and 2.9 months, respectively.

Safety:

● The median treatment duration was 6.5 cycles in the Anbenitamab Group and 3.0 cycles in the Control Group.

● The incidence of Grade 3 treatment-emergent adverse events (TEAEs) or above was 60.6% in the Anbenitamab Group and 51.6% in the Control Group, while the incidence of serious adverse events (SAEs) was 31.9% and 33.3%, respectively.

● The most frequently observed Grade 3 treatment-related adverse events (TRAEs) or above in the Anbenitamab Group included neutropenia (29.8%), leukopenia (21.3%), anemia (18.1%), diarrhea (8.5%) and asthenia (8.5%), while the most frequently observed Grade 3 TRAEs or above in the Control Group included leukopenia (24.7%), neutropenia (21.5%), anemia (10.8%), diarrhea (7.5%) and thrombocytopenia (5.4%). The incidence of cardiotoxicity in both groups were both 3.2%, indicating fewer cardiac concerns.

CONCLUSIONS

The interim analysis demonstrated that anbenitamab achieved superior efficacy in second-line or third-line HER2-positive gastric cancer patients who had been previously treated with trastuzumab. The study met both its primary endpoints of PFS and OS with statistically significant and clinically meaningful improvements, indicating its potential to change clinical practice guidelines for the treatment of second-line or above gastric cancer. Compared with the recently published DESTINY-Gastric04 results of DS-8201 in second-line gastric cancer, anbenitamab demonstrates potential advantages in both efficacy and safety.

Prompted by these encouraging results of anbenitamab, we are preparing to expand clinical development into first-line and perioperative gastric cancer through new registrational trials, aiming to extend benefits to more patients. Meanwhile, JSKN003, an ADC built upon KN026, has demonstrated high-security profile and distinctive advantages. With multiple registrational studies currently advancing as planned, we anticipate even more outstanding performance from JSKN003 in the future.

About Anbenitamab (KN026)

Anbenitamab (KN026) is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade.

Results from multiple clinical studies showed that KN026 has promising efficacy for the treatment of HER2-positive solid tumors, both in the first-line and in patients previously treated with trastuzumab. Currently, several pivotal trials of KN026 for second-line or above HER2-positive GC/gastroesophageal junction cancer (GEJ), first-line HER2-positive BC, neoadjuvant treatment of HER2-positive BC are being conducted. KN026 for the treatment of patients with HER2-positive GC who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA). KN026 for the treatment of HER2-positive or low expressing GC was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). In September 2025, the first New Drug Application (NDA) for anbenitamab injection has been accepted by the NMPA for use in combination with chemotherapy in patients with HER2-positive locally advanced, recurrent, or metastatic GC/GEJ who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, OCT 18, 2025, View Source [SID1234656997])

Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer

On October 18, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported detailed efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA WT, advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. As previously announced, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival ("PFS") versus fulvestrant, reducing the risk of disease progression or death by 76%. The gedatolisib doublet reduced the risk of progression or death by 67% versus fulvestrant.

The detailed study results were presented at a late breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress today, Saturday, October 18 at 4:25 a.m. ET/10:25 a.m. CEST.

In the trial, median PFS with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The topline efficacy data from the VIKTORIA-1 PIK3CA WT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

● The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of an endocrine therapy-based regimen.
● Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR ("PAM") pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
● The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC.

The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial, said: "VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in median PFS with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type disease, all of whom previously received a CDK4/6 inhibitor. With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, with less than one-half of the required number of events having occurred, showed promising trends for both the gedatolisib triplet and doublet.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity, said: "We are very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event. This safety profile combined with the 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens, offer potentially paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer."

Celcuity initiated a rolling New Drug Application ("NDA") submission in conjunction with the U.S. Food and Drug Administration’s ("FDA") Real-Time Oncology Review program, based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled and is expected to report topline data for this cohort in late Q1 2026 or during Q2 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call on Monday, October 20, 2025, at 8:00 a.m. ET to discuss the additional results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event.

Notes

HR+/HER2- Breast cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

VIKTORIA-1

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, OCT 18, 2025, View Source [SID1234656812])

Enhertu reduced the risk of disease recurrence or death by 53% vs. T-DM1 in patients with high-risk HER2-positive early breast cancer following neoadjuvant therapy in DESTINY-Breast05 Phase III trial

On October 18, 2025 Astrazeneca reported positive results from the DESTINY-Breast05 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) in patients with a high risk of disease recurrence. The trial compared Enhertu with trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment (after surgery) in patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment.

Results showed Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 as a post-neoadjuvant treatment (based on an IDFS hazard ratio [HR] of 0.47, 95% confidence interval [CI] 0.34-0.66, p<0.0001). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared with 83.7% of those in the T-DM1 arm. The IDFS results were consistent across all prespecified subgroups.

Enhertu also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, Enhertu lowered the risk of distant disease recurrence (distant recurrence-free interval [DRFI]) by 51% and the risk of brain metastases (brain metastasis-free interval [BMFI]) by 36% versus T-DM1.

Overall survival (OS) was not mature at the time of this planned interim analysis (2.9% maturity at data cut-off) and will be assessed in future analyses (HR 0.61; 95% CI 0.34-1.10).

Charles Geyer, MD, Chief Scientific Officer of the National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP) Foundation, Professor of Medicine at the UPMC Hillman Cancer Center and principal investigator for the trial, said: "For patients with residual disease after neoadjuvant treatment, the post‑neoadjuvant setting represents a critical second opportunity to reduce recurrence risk, and in DESTINY‑Breast05 Enhertu reduced the risk of early recurrence or death by 53 per cent compared to the current standard of T‑DM1. These results, coupled with the safety data from the trial, are likely to transform clinical practice in the post-neoadjuvant setting for patients with high-risk disease, with the potential for Enhertu to set a new standard of care."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Progress in treating HER2-positive early breast cancer has been significant, yet managing patients at a higher-risk of recurrence remains challenging. These landmark data, alongside those from DESTINY-Breast11, underscore the potential of Enhertu to become a foundational treatment in early-stage breast cancer, increasing the likelihood that more patients could be cured in this setting."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "The results of DESTINY-Breast05 demonstrate a clear benefit of Enhertu over the current standard of care in patients with high-risk HER2-positive early breast cancer following surgery, improving their chance for sustained long-term outcomes. These results, coupled with the results of DESTINY-Breast11, illustrate the continued promise of Enhertu to move earlier in the breast cancer treatment paradigm where it can have the greatest impact on the lives of patients."

Summary of Results: DESTINY-Breast05i

Efficacy Measure

Enhertu
(5.4 mg/kg; n=818)

T-DM1
(n=817)

IDFSii

3-year IDFS rate, %

92.4

83.7

HR 0.47 (95% CI 0.34-0.66); p<0.0001

DFSiii

3-year DFS rate, %

92.3

83.5

HR 0.47 (95% CI 0.34-0.66); p<0.0001

DRFIiv

3-year event-free rate, %

93.9

86.1

HR 0.49 (95% CI 0.34-0.71)

BMFIv

3-year event-free rate, %

97.6

95.8

HR 0.64 (95% CI 0.35-1.17)

OSvi

Survival at 3 years, %

97.4

95.7

HR 0.61 (95% CI 0.34-1.10)

TDM-1, trastuzumab emtansine; CI, confidence interval; HR, hazard ratio; IDFS, invasive disease-free survival; DFS, disease-free survival; DRFI, distant recurrence-free interval; BMFI, brain-metastasis-free interval; OS, overall survival

i Data cut-off 2 July 2025
ii IDFS is defined as the time from randomisation until the date of first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumour, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence or death from any cause; based on investigator assessment; statistically evaluated using the pre-specified hierarchical testing procedure
iii DFS is defined as the time between randomisation and the date of the first occurrence of an IDFS event per STEEP criteria, including second primary non-breast cancer event, or contralateral or ipsilateral ductal carcinoma in situ (DCIS); based on investigator assessment; statistically evaluated using the pre-specified hierarchical testing procedure
iv DRFI is defined as the time between randomisation and the date of distant breast cancer recurrence; based on investigator assessment
v BMFI is defined as the time between randomisation and the date of documentation of brain metastases or leptomeningeal disease; based on investigator assessment
vi 2.9% maturity

The safety profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Grade 3 or higher treatment emergent adverse events (AEs) rates were comparable between Enhertu and T-DM1 (50.6% versus 51.9%). Rates of interstitial lung disease (ILD) were low in both arms with ILD events occurring in 9.6% of the Enhertu arm and 1.6% of the T-DM1 arm. The majority of ILD events were low Grade (Grade 1 or 2). There were no Grade 3 or higher ILD events for T-DMI. There were seven Grade 3 events and no Grade 4 events in the Enhertu arm. There were two Grade 5 events in the Enhertu arm as determined by an independent adjudication committee.

The DESTINY-Breast05 results (abstract #LBA1) will be presented today during Presidential Symposium I alongside the results of the DESTINY-Breast11 Phase III trial (abstract #291O) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress in Berlin, Germany.

DESTINY-Breast05 was conducted in collaboration with the NSABP, the German Breast Group (GBG), Arbeitsgemeinschaft Gynäkologische Onkologie (AGO-B) and SOLTI Breast Cancer Research Group.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Post neoadjuvant treatment for HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer are considered HER2-positive.3

For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR and have poorer long-term outcomes, putting them at increased risk of disease recurrence.5-9

Post-neoadjuvant therapy represents a key opportunity to minimise the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. Despite receiving additional treatment with T-DMI in the post-neoadjuvant setting, approximately 20% of patients still experience invasive disease or death and no reduction in the risk of CNS recurrence.10,11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast and/or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS. IDFS is defined as the time from randomisation until first recurrence, distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include OS, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2-monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+ or in-situ hybridisation (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway (datopotamab deruxtecan), and next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab).

(Press release, AstraZeneca, OCT 18, 2025, View Source [SID1234656784])

Enhertu followed by THP before surgery resulted in a pathologic complete response in 67% of patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial

On October 18, 2025 Astrazeneca reported positive results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate. The trial compared Enhertu followed by THP with dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment.

In DESTINY-Breast11, Enhertu followed by THP resulted in a pCR rate of 67.3% compared with 56.3% for ddAC-THP, representing a pCR rate improvement of 11.2%. Improvement in pCR rates was observed across both hormone receptor (HR)-positive and HR-negative subgroups (HR-positive: 61.4% versus 52.3%; HR-negative: 83.1% versus 67.1%). Additionally, after surgery, 81.3% of patients who received neoadjuvant treatment in the Enhertu followed by THP arm had no or minimal residual invasive cancer (residual cancer burden [RCB] 0+I) detected in the resected breast or lymph node tissue compared to 69.1% of patients in the comparator arm.

The secondary endpoint of event-free survival (EFS) was not mature at the time of this analysis (4.5% maturity at data cutoff); however, an early analysis showed a trend favouring Enhertu followed by THP versus ddAC-THP (hazard ratio 0.56; 95% CI 0.26-1.17).

Nadia Harbeck, MD, PhD, Director of Breast Center, Cancer Department of OB&GYN and CCC Munich, LMU University Hospital, Germany and principal investigator for the trial, said: "For patients with early breast cancer who are at high risk of disease recurrence, using the most effective treatment option at the earliest opportunity is critical to prevent recurrence, optimise safety and improve the potential for cure. In the DESTINY-Breast11 trial, more than two thirds of patients had a pathologic complete response with trastuzumab deruxtecan followed by THP, suggesting a potential new standard of care in the neoadjuvant setting for patients with high-risk, HER2-positive early breast cancer."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The goal of treatment in the early breast cancer setting is to provide patients with the best possible chance for cure whilst optimising the tolerability of the treatment regimen. The impressive pathologic response rates and favourable safety profile seen with Enhertu followed by THP in DESTINY-Breast11 have the potential to transform treatment in the neoadjuvant setting and underscore the importance of bringing Enhertu into earlier stages of HER2-positive disease."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "While achieving a pathologic complete response in HER2-positive early-stage breast cancer is critical for reducing disease recurrence and improving long-term prognosis, approximately half of patients still show evidence of residual disease following surgery with currently available neoadjuvant treatment options. The results from DESTINY-Breast11 show that treatment with Enhertu followed by THP prior to surgery resulted in no evidence of residual invasive disease in two thirds of patients, illustrating the first treatment regimen in more than a decade to significantly improve outcomes in the earliest treatment setting for HER2-positive breast cancer."

Summary of Results: DESTINY-Breast11i,ii

Efficacy Measure

Enhertu (5.4 mg/kg; 4 cycles) followed by THP (4 cycles) (n=321)

ddAC (4 cycles) followed by THP (4 cycles)
(n=320)

pCR

pCR rate, %iii

67.3

56.3

ΔpCR,% (95% CI)iii,iv

11.2 (4.0-18.3)

p=0.003

HR-positive subgroup pCR rate, %iii

61.4

52.3

ΔpCR, % (95% CI)

9.1 (0.2-17.9)

HR-negative subgroup pCR rate, % iii

83.1

67.1

ΔpCR, % (95% CI)

16.1 (3.0-28.8)

RCB (0+I)v

RCB (0+I rate), %

81.3

69.1

ΔRCB, %

12.2

RCB-I rate, %

68.8

57.5

RCB-0 rate, %

12.5

11.6

HR-positive subgroup RCB (0+I) rate, %

78.0

64.7

ΔRCB, % (95% CI)

13.3

HR-positive RCB-I rate, %

63.1

52.8

HR-positive RCB-0 rate, %

14.8

11.9

HR-negative subgroup RCB (0+I) rate, %v

90.4

81.2

ΔpCR, % (95% CI)

9.2

HR-negative RCB-I rate, %

84.3

70.6

HR-negative RCB-0 rate, %

6.0

10.6

EFSvi

2-year EFS, %

Hazard ratio (95% CI)

96.9

93.1

0.56 (0.26, 1.17)

THP, paclitaxel, trastuzumab and pertuzumab; ddAC, dose-dense doxorubicin and cyclophosphamide; pCR, pathologic complete response; HR, hormone receptor; CI, confidence interval; RCB (0+I), residual cancer burden; EFS, event-free survival

i Data cut-off 12 March 2025; median duration of follow up was 24.2 months with Enhertu followed by THP and 23.6 months with ddAC-THP
ii Based on blinded central review
iii pCR responders were defined as patients who only received randomised study treatment (at least one dose) and had pCR
iv Stratified Miettinen & Nurminen method; p value crossed the 0.03 prespecified boundary
v RCB is based on raw data and is not corrected for non-starters, or any bridging/off study neoadjuvant treatment; therefore, there may be differences between pCR and RCB-0
vi EFS was 4.5% mature at interim analysis

The safety profile of Enhertu followed by THP in DESTINY-Breast11 was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu followed by THP showed a favourable safety profile compared with ddAC-THP with reduced rates of Grade 3 or higher adverse events (AEs) (37.5% versus 55.8%), serious AEs (10.6% versus 20.2%), treatment interruptions (37.8% versus 54.5%) and left ventricular dysfunction (1.3% versus 6.1%).

Rates of interstitial lung disease (ILD) were low and similar between arms with ILD events occurring in 4.4% of patients in the Enhertu followed by THP arm compared with 5.1% in the ddAC-THP arm. The majority of ILD events were low Grade (Grade 1 and 2). There was one Grade 3/4 event in the Enhertu followed by THP arm and five Grade 3/4 events in the ddAC-THP arm. There was one Grade 5 ILD event in each arm as determined by an independent adjudication committee.

DESTINY-Breast11 results (abstract #291O) will be presented today during Presidential Symposium I, alongside the results from the DESTINY-Breast05 Phase III trial (abstract #LBA1) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress in Berlin, Germany. The DESTINY-Breast11 results will also be published in the Annals of Oncology in parallel with ESMO (Free ESMO Whitepaper).

A supplemental Biologics License Application for Enhertu followed by THP based on the results from DESTINY-Breast11 is currently under review by the US Food and Drug Administration (FDA).

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

Notes

HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer are considered HER2-positive.3

Approximately one in three patients with HER2-positive early breast cancer are considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis.4 For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR.6-10

The current standard of care in the HER2-positive neoadjuvant setting in many regions of the world consists of combination chemotherapy regimens.11 These regimens often include anthracyclines, which can be challenging for patients to tolerate and may result in long-term cardiotoxicity, reinforcing the need for new treatment options.11-13

DESTINY-Breast11
DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4 mg/kg) monotherapy or Enhertu followed by THP (paclitaxel, trastuzumab and pertuzumab) versus ddAC-THP in patients with high-risk (lymph node positive [N1-3] or primary tumour stage T3-4), locally advanced or inflammatory HER2-positive early-stage breast cancer.

Patients were randomised 1:1:1 to receive either eight cycles of Enhertu monotherapy; four cycles of Enhertu followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The Enhertu monotherapy arm was closed early following a recommendation from the Independent Data Monitoring Committee (IDMC). The recommendation was based on multiple factors including a lower pCR rate, low likelihood that Enhertu alone would be superior to ddAC-THP, and timing of surgery. The recommendation was not related to safety.

The primary endpoint of DESTINY-Breast11 is rate of pCR (absence of invasive disease in the breast and lymph nodes). Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, AstraZeneca, OCT 18, 2025, View Source [SID1234656783])