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ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

On January 19, 2026 The European Medicines Agency (EMA) reported that it has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.

"This validation in the EU is an important step in moving us closer to offering ENHERTU in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring ENHERTU to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade."

About DESTINY-Breast09
DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) 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, objective response rate, 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.

About HER2 Positive Metastatic 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 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or that have progressed to metastatic disease are expected to live five years following diagnosis.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification.3 Approximately one in five cases of breast cancer are considered HER2 positive.4

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.4 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.5,6,7 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.8,9

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) 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 program 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) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or 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 90 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 60 countries/regions worldwide 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 (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors 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 80 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, DESTINY-Gastric04 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 tumors 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.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program 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.

(Press release, Daiichi Sankyo, JAN 19, 2026, View Source [SID1234662087])

Guardant Health Announces Multi-Year Strategic Collaboration Agreement with Merck to Develop Companion Diagnostics and Commercialize New Cancer Therapies Using Guardant Infinity Smart Platform

On January 19, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a multi-year collaboration with Merck, known as MSD outside the United States and Canada, to support the development and commercialization of Merck’s oncology portfolio using the Guardant Infinity Smart platform.

Under the multi-year collaboration agreement, Guardant and Merck aim to:

Use Guardant’s portfolio of liquid and tissue biopsy tests as clinical trial enrolling assays in Merck’s global clinical studies,
Evaluate opportunities to develop novel therapies using Guardant liquid biopsy tests as a companion diagnostic, and
Partner for global commercialization of drugs and companion diagnostics including in US, Asia-Pacific, UK and EU markets.
"This strategic collaboration allows us to bring the power of the Infinity Smart platform to some of the most important oncology programs in development today," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "As biomarkers become more central to therapy selection, our goal is to ensure that every trial has the molecular clarity needed to reach the right patients. This collaboration strengthens our shared commitment to rigor, scale, and faster development of life-changing cancer therapies."

(Press release, Guardant Health, JAN 19, 2026, View Source [SID1234662086])

AbelZeta Announces Remaining China Rights to GPC3 Armored CAR-T Therapy to be Acquired by AstraZeneca

On January 18, 2026 AbelZeta Pharma, Inc. ("AbelZeta"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported that AstraZeneca has agreed to acquire AbelZeta’s 50% share of the China development and commercialization rights to C-CAR031, such that AstraZeneca acquires the sole right to develop, manufacture and commercialize C-CAR031 globally. Under the terms of the agreement, AbelZeta will be entitled to receive up to $630 million from AstraZeneca including an upfront payment, and development, regulatory and sales milestone payments for the GPC3 program in China.

Under the terms of a prior agreement with AbelZeta, AstraZeneca owns the development, manufacturing and commercialization rights to C-CAR031 in rest of world, outside of China. AbelZeta is also eligible to receive additional milestone payments and royalties for rest of world development.

"This transaction reflects our commitment to leverage our platform technology to develop novel cell therapies in solid tumors of high unmet medical need, including Hepatocellular carcinoma (HCC), and provides the opportunity to maximize C-CAR031’s global reach" said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta.

C-CAR031 is an autologous, Glypican 3 (GPC3)-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, designed using AstraZeneca’s dominant negative transforming growth factor-beta receptor II armoring platform, and is currently being investigated for the treatment of HCC and other solid tumors.

About HCC
Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Several types of primary liver cancer occur in adults, HCC being the most common form. About 75% of all primary liver cancers in adults are HCC. Liver cancers are categorized based on the originating cell type. HCC begins in the liver as either a single tumor or several small nodules and at this local stage, it can be treated by locally targeted or surgical methods. However, most patients are diagnosed at advanced-stage, or their disease progresses to advanced-stage HCC when the prognosis is poor, with a 5-year survival rate of only 7% and a median survival of approximately 20 months. According to Frost & Sullivan, the incidence of HCC in China has been growing steadily to approximately 344,500 cases in 2024.

(Press release, AbelZeta, JAN 18, 2026, View Source [SID1234662082])

D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002

On January 18, 2026 D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:

D3S‑003 — a KRAS G12D inhibitor — enabling the start of a Phase 1 first‑in‑human clinical trial.
A Phase 2 combination trial evaluating D3S‑001 (elisrasib), the Company’s next‑generation KRAS G12C inhibitor, in combination with D3S‑002, a selective oral ERK1/2 inhibitor.
D3S‑003 is an orally bioavailable, allele‑specific KRAS G12D inhibitor that targets both the GDP‑bound (OFF) and GTP‑bound (ON) conformations. Preclinical data demonstrate a differentiated, best‑in‑class profile with potent anti‑tumor activity, favorable drug‑like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S‑003 into a Phase 1 first‑in‑human study in patients with advanced solid tumors harboring KRAS G12D mutations.

The newly cleared Phase 2 study will evaluate the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C‑targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS‑driven cancers.

"We are excited to receive FDA IND clearance for D3S‑003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S‑002," said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "With D3S‑003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S‑002 pushes forward our next‑generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C‑targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS‑mutant cancers who urgently need new options."

About Elisrasib (D3S-001)

Elisrasib is a next‑generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP‑bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

Cancer Discovery (2024) 14(9):1675–1698
Nature Medicine (2025) 31(8):2768–2777
About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.
About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS‑driven cancers.

(Press release, D3 Bio, JAN 18, 2026, View Source [SID1234662080])

Repare Shareholders Approve Acquisition by XenoTherapeutics, Inc.

On January 16, 2026 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported that its Shareholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of the Common Shares, the "Shareholders") by XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly "Xeno") a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement") at the special meeting of Shareholders held today (the "Meeting").

The special resolution approving the Arrangement was approved by: (i) 99.76% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, and (ii) 99.76% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61- 101 Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.34% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (i) the voluntary liquidation and dissolution of the Company by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (ii) the appointment of KPMG LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Superior Court of Québec (the "Court") and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on January 23, 2026 and, assuming receipt of the approval of the Court and satisfaction of other customary conditions to closing, the completion of the Arrangement is expected to occur on or about January 28, 2026.

(Press release, Repare Therapeutics, JAN 16, 2026, View Source [SID1234662076])