On September 24, 2025 AstraZeneca and Daiichi Sankyo reported that its supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been accepted and granted Priority Review in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (Press release, AstraZeneca, SEP 24, 2025, View Source [SID1234656200]).

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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2026.

Enhertu was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.1,2 Approximately 10,000 patients are treated each year in the 1st-line HER2-positive metastatic setting in the US.3

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The DESTINY-Breast09 trial showed that treating patients with HER2-positive metastatic breast cancer with Enhertu in combination with pertuzumab until progression in the first-line setting produced a new landmark of more than 40 months for progression-free survival and nearly doubled the number of patients with no evidence of disease on imaging. This marks the first major evolution in treatment in this first-line setting in more than a decade – a setting where a strong response is crucial, as up to one third of patients may not receive second-line therapy."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "Enhertu in combination with pertuzumab delayed disease progression for more than three years compared to around two years with current standard of care as a first-line treatment for patients with HER2-positive metastatic breast cancer. Receiving Priority Review moves us closer to offering Enhertu to patients even earlier in the metastatic treatment pathway as a potential new first-line treatment option."

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme, an initiative of the FDA designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application.

The sBLA is based on data from the DESTINY-Breast09 Phase III trial presented as a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval 0.44-0.71; p<0.00001) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.

Median progression-free survival (PFS) was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP. The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups.

Confirmed objective response rate (ORR) with Enhertu plus pertuzumab was 85.1% versus 78.6% with THP. There were 58 complete responses (CRs) with Enhertu plus pertuzumab compared to 33 CRs with THP.

The safety profile of Enhertu plus pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified.

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.

Enhertu is already approved in more than 85 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03 Phase III trial.

Notes

HER2-positive metastatic breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.4 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.4 In the US, more than 300,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.5 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.6

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.7,8 HER2 protein overexpression may occur as a result of HER2 gene amplification.9 Approximately one in five cases of breast cancer are considered HER2-positive.1

While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.9-12 Further, approximately 25-30% of patients do not go on to receive treatment following 1st-line therapy due to discontinuation or death.13-15

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a 1st-line treatment in patients with HER2-positive metastatic breast cancer.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, 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 (5.4mg/kg) is approved in more than 85 countries 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 (or one or more) 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 (5.4mg/kg) is approved in more than 85 countries 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 (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (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 (5.4mg/kg) is approved in more than 60 countries 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.

Enhertu (6.4mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 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 will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu (5.4 mg/kg) is approved in more than 10 countries 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 clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

On September 24, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that the first prospective validation data for a molecular signature to predict hormone therapy benefit in men with recurrent prostate cancer will be presented at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology (Press release, Veracyte, SEP 24, 2025, View Source [SID1234656199]). The findings were derived using Veracyte’s Decipher GRID (Genomic Resource for Intelligent Discovery) research tool. The study is among nine Decipher-focused abstracts—including six selected for podium presentations—in prostate cancer that will be presented at the conference, being held September 27 to October 1 at the Moscone Center in San Francisco.

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"We look forward to the presentation of important new data examining the role of adverse molecular features in predicting disease progression and treatment response for patients with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Such insights will ultimately make prostate cancer care more precise, giving greater molecular dimension to the classification and treatment of the disease. We believe that our Decipher GRID research tool, combined with our extensive database of prostate tumor whole-transcriptome-derived genomic profiles—the largest of its kind in prostate cancer research—uniquely positions Veracyte to usher in the next generation of cancer diagnostics."

The following Decipher-focused presentations examining the role of adverse molecular features in prostate cancer are among those being presented at ASTRO 2025:

Title:

A Double-Blinded Placebo-Controlled Biomarker Stratified Randomized Trial of Apalutamide (APA) and Radiotherapy for Recurrent Prostate Cancer (NRG GU006, BALANCE trial) (LBA-04)

Presenter:

Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University

Format:

Podium

Date/Time:

Sunday, Sept. 28; 1:00-1:10 p.m. PDT

Room:

San Francisco Ballroom

Title:

Discordance of Adverse Molecular Features between the 22-Gene Genomic Classifier Score, Histologic Grade, and NCCN Risk Groups: Analysis of Over 200,000 Patients​ (Abstract #1116)

Presenter:

Michael Zelefsky, M.D., FASTRO, NYU Langone Laura and Isaac Perlmutter Cancer Center

Format:

Podium

Date/Time:

Wednesday, Oct. 1, 8:15-8:20 a.m. PDT

Room:

155/157

Information about all of the Decipher-related abstracts being presented at ASTRO 2025 can be found here. Meeting attendees can also visit Veracyte’s booth (#3001).

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found.

On September 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that management is scheduled to participate in the following investor conference (Press release, Kura Oncology, SEP 24, 2025, View Source [SID1234656198]).

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UBS Virtual Oncology Day
Wednesday, October 1, 2025
2:30 p.m. ET / 11:30 a.m. PT

A live audio webcast will be available in the Investors section of Kura’s website at View Source, with an archived replay available following the event.

On September 24, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported a proposed underwritten public offering of shares of its Class A common stock or, in lieu of Class A common stock, pre-funded warrants to purchase Class A common stock (the "Offering") (Press release, Immuneering, SEP 24, 2025, View Source [SID1234656196]). In addition, Immuneering intends to grant the underwriters a 30-day option to purchase up to a number of additional shares of Class A common stock equal to fifteen percent (15%) of the shares of Class A common stock and pre-funded warrants initially offered in the Offering. Immuneering also announced that Sanofi has entered into a securities purchase agreement with Immuneering pursuant to which Sanofi has agreed to purchase $25.0 million of shares of Immuneering’s Class A common stock or, in lieu of such shares of Class A common stock, shares of Immuneering’s non-voting Class B common stock, at a price per share equal to the price to the public of the Class A common stock in the Offering, in a separate private placement transaction that is expected to close concurrently with the Offering (the "Private Placement"). All securities to be sold in the Offering and the Private Placement will be offered by Immuneering. The Offering is subject to market and other conditions, and the Private Placement is contingent upon the closing of the Offering, and there can be no assurance as to whether or when the Offering or Private Placement may be completed, or as to the actual size or terms of the Offering or the Private Placement.

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Immuneering intends to use the net proceeds of the Offering and the Private Placement to advance the preclinical and clinical development of its product candidates and for working capital and other general corporate purposes.

Leerink Partners and Oppenheimer & Co. Inc. are acting as the joint bookrunners for the Offering and as placement agents in connection with the Private Placement.

The Offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by Immuneering with the Securities and Exchange Commission (the "SEC") on August 13, 2025 and declared effective by the SEC on August 20, 2025. A preliminary prospectus supplement relating to the Offering will be filed with the SEC. Copies of the preliminary prospectus supplement relating to the offering, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected], or by visiting the EDGAR database on the SEC’s website at www.sec.gov.

The shares to be sold in the Private Placement have not been and will not be registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 24, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with 9 months median follow up (Press release, Immuneering, SEP 24, 2025, View Source [SID1234656195]). The data, to be presented at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025, marks a milestone for the Company in the treatment of one of the deadliest and most treatment-resistant solid tumors. The Company also announced it will not be hosting its previously scheduled conference call.

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"Overall survival is the gold standard in oncology and has been Immuneering’s goal from the very beginning. In cancer nothing matters more than keeping patients alive and helping them thrive. We are beyond thrilled to report that not only was our extraordinary 94% overall survival at 6 months sustained with additional follow up time, but that our observed 9-month overall survival of 86% shows an even larger gap with standard of care benchmarks," said Ben Zeskind, Ph.D., CEO of Immuneering. "To combine such meaningful overall survival with such favorable tolerability has the potential to be truly game-changing for first-line pancreatic cancer patients."

Extraordinary and Growing Survival Advantage Observed
Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable overall survival (OS) and progression-free survival (PFS) at 9 months median follow up in first-line pancreatic cancer patients (N=34). The MPACT pivotal trial for the standard of care, gemcitabine/nab-paclitaxel, reported significantly lower OS and PFS at 9 months.

OS observed at 9 months was 86% in patients receiving atebimetinib + mGnP. The median OS was not yet reached as of the data cutoff date. The standard of care reported a ~47% OS at 9 months.
As previously reported, OS observed at 6 months was 94% in patients receiving atebimetinib + mGnP. The standard of care reported a 67% OS at 6 months.
PFS observed at 9 months was 53% in patients receiving atebimetinib + mGnP. The standard of care reported a ~29% PFS at 9 months.
PFS observed at 6 months was 70% in patients receiving atebimetinib + mGnP. The standard of care reported a ~44% PFS at 6 months.
Unless otherwise specified, all data are reported using a data cutoff date of August 26, 2025, from the same patient cohort (N=34) as previously reported in June 2025. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care set forth above with respect to the six-month follow-up data were reported out directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company’s Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.

The Company believes these compelling updated survival data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP.

Favorable Tolerability Profile Observed:

As of the data cutoff date, Atebimetinib (320mg dosed once-daily) + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients (N=34), with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy). No new safety signals were identified.

Safety Data for Pivotal Trials and for Atebimetinib + mGnP in 1L PDAC

How Did Atebimetinib Achieve Such Extraordinary Survival?

Atebimetinib is a Deep Cyclic Inhibitor: A New Paradigm in Targeted Therapy

Immuneering’s proprietary Deep Cyclic Inhibitors (DCIs) challenge the conventional model of sustained or continuous inhibition in oncology.
Most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily.
Deep Cyclic Inhibitors are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably.
Sustained inhibition also causes suppressed transient signaling in healthy cells, leading to many adverse events.
Deep Cyclic Inhibitors aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events.

Atebimetinib Targets MEK: A Broader, Potentially More Durable Approach

MEK is a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers.
Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

"Deep Cyclic Inhibitors like atebimetinib represent a fundamental shift in targeted therapy, away from continuous inhibition and toward pulsatile modulation of key oncogenic pathways," said Brett Hall, Ph.D., Chief Scientific Officer at Immuneering. "This approach has the potential to deliver both durability and tolerability, two patient-centered essentials oncology has long struggled to balance."

"Pancreatic cancer remains one of the most challenging cancers we face in the clinic with far too few treatment options available to patients and survival rates that have remained unacceptably low for decades," said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, principal investigator of the Phase 2a clinical trial and a paid member of the company’s scientific advisory board. "I have seen firsthand in my own patients the benefits of atebimetinib’s durability and tolerability. The remarkable overall survival, progression-free survival, and tolerability data we are seeing with atebimetinib + mGnP in first-line pancreatic cancer patients, now out to 9 months of median follow up, represent an important step towards creating urgently needed new options for these patients. We are also planning a confirmatory study."

Near-Term Milestone Expectations

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including:

Regulatory feedback on pivotal trial plans in Q4 2025
Announcing further updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP, including at a scientific conference in 2026
Pending regulatory feedback, initiating a pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer by the end of 2025, and dosing the first patient by mid-2026
Initiating additional atebimetinib clinical trial combination arms in 2026, including in non-small cell lung cancer