On January 22, 2026 Israel Cancer Research Fund (ICRF) and the Cancer Research Institute (CRI) reported to have partnered on a new award, the ICRF-CRI Immunotherapy Collaborative Project Grant, given to Dr. Asaf Madi, PhD, of Tel Aviv University. Dr. Madi was awarded $180,000 over a three-year period to support his research on refining tumor-infiltrating lymphocyte (TIL) therapy to predict response and overcome drug resistance in melanoma.

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"We are honored to once again partner with CRI, a world-class immunotherapy research organization, on this cutting-edge project," said Alan Herman, ICRF’s Executive Director. "There is a clear, unmet need for personalized treatments like TIL therapy, and Dr. Madi’s research into adoptive cell transfer could offer new hope to melanoma patients in urgent need of better options."

Adoptive cell transfer (ACT) using TILs is a promising personalized immunotherapy for melanoma, shown to improve survival in advanced cases. However, many patients do not respond, and others develop resistance, limiting the long-term effectiveness of this approach. Dr. Madi’s research aims to address these challenges by identifying predictive biomarkers, uncovering mechanisms of tumor resistance, and optimizing TIL selection and expansion to improve therapeutic outcomes.

Dr. Madi and his team are studying the gene circuits that program immune cells, controlling their differentiation, activation, and regulation. By examining how T cells behave in tumors, particularly following immunotherapy, they aim to determine why some T cells sustain anti-tumor activity while others become exhausted or suppressed. Insights from this work will guide the selection and engineering of more potent TIL populations capable of durable tumor targeting and generating long-term immune memory, reducing the risk of cancer recurrence.

"This collaboration reflects what progress in immunotherapy really looks like—bringing together partners, data, and discovery to tackle resistance head-on," said Alicia Zhou, PhD, CEO of CRI. "By understanding why some immune cells persist while others fail, Dr. Madi’s work moves us closer to making personalized cell therapies like TILs more reliable, more durable, and more transformative for patients with melanoma."

Melanoma is the deadliest form of skin cancer. In the U.S. alone, over 100,000 new cases are diagnosed each year, and advanced melanoma can be resistant to standard treatments. Because it can spread quickly and evade therapies, developing new, effective treatments is critical to improve survival and offer hope to patients and their families worldwide.

Dr. Asaf Madi earned his Ph.D. in computational immunology at Tel Aviv University in collaboration with the Weizmann Institute of Science, studying B cell and T cell repertoires. He then completed a postdoctoral fellowship at Harvard Medical School and the Broad Institute, focusing on T-cell differentiation and cancer immunology. Dr. Madi then returned to Tel Aviv University, where he is now an Associate Professor in the Department of Pathology, leading a team that drives the development of novel anti-cancer therapies.

(Press release, Cancer Research Institute, JAN 22, 2026, View Source [SID1234662175])

On January 22, 2026 CorriXR Therapeutics, an oncology focused biotherapeutics company developing genetic medicines to overcome drug resistance in solid tumors, reported that its novel CRISPR-directed disruption of the transcription factor NRF2 can restore chemosensitivity in head and neck and esophageal squamous cell carcinoma models. The preclinical data were published in Molecular Therapy Oncology. The study, conducted in collaboration with scientists at ChristianaCare’s Gene Editing Institute (GEI), reinforces CorriXR’s previously reported data in lung cancer models and highlights how CRISPR targeting of NRF2 can disrupt tumor cells’ protective mechanisms and potentially boost patients’ bodies’ ability to respond more effectively to standard chemotherapy.

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"For patients with solid tumor cancers, once their tumors become resistant to chemotherapy, treatment options narrow and are often more toxic to them," said Eric B Kmiec, Ph.D., Founder and Chief Executive Officer of CorriXR Therapeutics and Executive Director of GEI. "These data from CorriXR’s first-in-class editing approach suggest that by precisely disrupting NRF2, we may be able to reopen the window to standard treatments and potentially do so at lower doses; this could translate into better control of disease with fewer side effects for patients."

NRF2 is a master regulator of cellular stress responses and a well-established driver of treatment resistance in multiple cancers, making it an attractive but historically "undruggable" target for therapeutic intervention. CorriXR is advancing essential studies to support an IND filing in head and neck squamous cell carcinoma (HNSCC) as a potential first clinical indication.

Head and neck cancer, 90% of which is HNSCC, is the seventh most diagnosed cancer worldwide, with annual incidence predicted to reach one million new cases by 2030. With 50% of patients experiencing recurrence within two years, there is a significant need for new approaches that can overcome resistance to current treatment paradigms. CorriXR anticipates completion of additional in vivo studies in HNSCC in combination with chemotherapy and radiation in the first half of 2026.

Study Overview

Researchers used CRISPR/Cas9 complexes to disrupt NRF2 in hypopharyngeal (FaDu) and esophageal (KYSE‑410) squamous cell carcinoma cells and then assessed gene editing outcomes, NRF2 pathway activity, and response to cisplatin and 5‑fluorouracil. Key study findings include:

High levels of on-target editing produced substantial reductions in NRF2 protein levels, decreased expression of downstream stress response genes, and significantly restored chemosensitivity.
Genetic disruption of NRF2 alone is sufficient to disrupt its ability to activate the genes that defend tumor cells.
Enhanced chemosensitivity after NRF2 disruption persisted over time, creating a treatment window for combination therapy.
The choice of CRISPR editing site on NRF2 influences both the functional impact on NRF2 and which cells are affected by the edit. Editing that disrupts a functional binding domain enables an approach that is agnostic to and independent of genetic mutations in the cancer cells.
"These findings complement previously published data from CorriXR and GEI showing that tumor-specific NRF2 editing in lung cancer models can resensitize tumors to standard chemotherapy and reduce tumor growth in vivo, thereby reinforcing NRF2 as a central node for overcoming drug resistance," said Natalia Rivera-Torres, Ph.D., lead author of the study and Associate Director of Research at GEI.

Kmiec added, "What is most encouraging about this work is that we are giving existing drugs a second chance to work in tumors that have learned how to evade them, enabling patients to benefit more, and longer, from proven regimens, with a better quality of life."

(Press release, CorriXR Therapeutics, JAN 22, 2026, View Source [SID1234662176])

On January 22, 2026 Abbott (NYSE: ABT) reported financial results for the fourth quarter ended Dec. 31, 2025.

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Fourth-quarter sales increased 4.4 percent on a reported basis, 3.0 percent on an organic basis, or 3.8 percent when excluding COVID-19 testing-related sales1.
Fourth-quarter GAAP diluted EPS of $1.01 and adjusted diluted EPS of $1.50, which excludes specified items and reflects growth of 12 percent.
Full-year 2025 sales of $44.3 billion increased 5.7 percent on a reported basis, 5.5 percent on an organic basis, or 6.7 percent when excluding COVID-19 testing-related sales2.
Full-year 2025 GAAP diluted EPS of $3.72 and adjusted diluted EPS of $5.15, which excludes specified items and reflects growth of 10 percent.
Abbott projects full-year 2026 organic sales growth to be in the range of 6.5% to 7.5%.
Abbott projects full-year 2026 adjusted diluted EPS of $5.55 to $5.80, which reflects growth of 10 percent at the midpoint.
In November, Abbott announced an agreement to acquire Exact Sciences, a move that will position the company to enter and lead in the fast-growing cancer diagnostics market. Abbott continues to expect the transaction to close in the second quarter of 2026.
Abbott expanded its leadership in Electrophysiology with two significant regulatory approvals:
In December, Abbott announced U.S. Food and Drug Administration (FDA) approval for its Volt PFA System, bringing Abbott’s first pulsed field ablation (PFA) offering to patients in the United States.
In January, Abbott announced the company obtained CE Mark for its TactiFlex Duo Ablation Catheter, Sensor Enabled, designed to deliver radiofrequency (RF) and PFA energy to treat patients battling atrial fibrillation.
"In 2025, we expanded margins and achieved double-digit earnings per share growth, our new product pipeline was highly productive, and we took important strategic steps to shape the company for the future," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re well positioned for accelerating growth in 2026."

FOURTH-QUARTER BUSINESS OVERVIEW

Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,383

806

967

—

2,605

International

7,076

1,134

1,490

1,382

3,070

Total reported

11,459

1,940

2,457

1,382

5,675

% Change vs. 4Q24

U.S.

0.9

(13.2)

(8.4)

n/a

10.7

International

6.7

(5.6)

1.8

9.0

13.7

Total reported

4.4

(8.9)

(2.5)

9.0

12.3

Impact of foreign exchange

1.4

0.2

1.1

2.0

1.9

Organic

3.0

(9.1)

(3.6)

7.0

10.4

Impact of COVID-19 testing sales 1

(0.8)

—

(3.4)

—

—

Organic (excluding COVID-19 tests)

3.8

(9.1)

(0.2)

7.0

10.4

Organic

U.S.

0.9

(13.2)

(8.4)

n/a

10.7

International

4.3

(5.9)

(0.2)

7.0

10.1

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

17,126

3,606

3,535

—

9,968

International

27,202

4,845

5,402

5,536

11,419

Total reported

44,328

8,451

8,937

5,536

21,387

% Change vs. 12M24

U.S.

4.9

(2.3)

(7.7)

n/a

13.4

International

6.1

2.6

(2.0)

6.6

12.0

Total reported

5.7

0.4

(4.3)

6.6

12.6

Impact of foreign exchange

0.2

(0.7)

0.2

(0.8)

0.7

Impact of business exit*

—

(0.1)

—

—

—

Organic

5.5

1.2

(4.5)

7.4

11.9

Impact of COVID-19 testing sales 2

(1.2)

—

(4.9)

—

—

Organic (excluding COVID-19 tests)

6.7

1.2

0.4

7.4

11.9

Organic

U.S.

5.0

(1.9)

(7.7)

n/a

13.4

International

5.9

3.7

(2.3)

7.4

10.5

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

806

463

343

International

1,134

439

695

Total reported

1,940

902

1,038

% Change vs. 4Q24

U.S.

(13.2)

(17.7)

(6.3)

International

(5.6)

0.3

(8.9)

Total reported

(8.9)

(9.8)

(8.1)

Impact of foreign exchange

0.2

0.3

0.1

Organic

(9.1)

(10.1)

(8.2)

U.S.

(13.2)

(17.7)

(6.3)

International

(5.9)

(0.3)

(9.1)

Worldwide Nutrition sales decreased 8.9 percent on a reported basis and 9.1 percent on an organic basis in the fourth quarter.

Results in the quarter reflect the impact of lower sales volumes compared to the prior year and new strategic price actions targeted to increase volume growth in the future. In addition to these strategic price actions, Abbott expects to increase volume growth with the launch of several new products in 2026.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Pediatric

Adult

U.S.

3,606

2,158

1,448

International

4,845

1,816

3,029

Total reported

8,451

3,974

4,477

% Change vs. 12M24

U.S.

(2.3)

(2.3)

(2.2)

International

2.6

0.1

4.1

Total reported

0.4

(1.2)

2.0

Impact of foreign exchange

(0.7)

(0.5)

(0.7)

Impact of business exit*

(0.1)

—

(0.3)

Organic

1.2

(0.7)

3.0

U.S.

(1.9)

(2.3)

(1.4)

International

3.7

1.3

5.1

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid Diagnostics

U.S.

967

376

39

107

445

International

1,490

1,085

102

51

252

Total reported

2,457

1,461

141

158

697

% Change vs. 4Q24

U.S.

(8.4)

3.6

2.9

6.5

(19.7)

International

1.8

5.9

3.3

9.8

(14.1)

Total reported

(2.5)

5.3

3.2

7.5

(17.8)

Impact of foreign exchange

1.1

1.7

2.1

0.4

0.3

Organic

(3.6)

3.6

1.1

7.1

(18.1)

U.S.

(8.4)

3.6

2.9

6.5

(19.7)

International

(0.2)

3.6

0.4

8.3

(14.9)

Global Diagnostics sales decreased 2.5 percent on a reported basis, decreased 3.6 percent on an organic basis, and decreased 0.2 percent when excluding COVID-19 testing-related sales1.

COVID-19 testing-related sales were $89 million in the quarter, compared to $176 million in the fourth quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 5.3 percent on a reported basis and increased 3.6 percent on an organic basis. Growth in other geographies was partially offset by challenging market conditions in China, including the impact of volume-based procurement programs.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid Diagnostics

U.S.

3,535

1,425

150

422

1,538

International

5,402

3,935

367

184

916

Total reported

8,937

5,360

517

606

2,454

% Change vs. 12M24

U.S.

(7.7)

7.0

0.4

3.4

(20.8)

International

(2.0)

0.8

(1.1)

2.5

(13.3)

Total reported

(4.3)

2.4

(0.7)

3.1

(18.1)

Impact of foreign exchange

0.2

0.3

0.5

—

(0.1)

Organic

(4.5)

2.1

(1.2)

3.1

(18.0)

U.S.

(7.7)

7.0

0.4

3.4

(20.8)

International

(2.3)

0.4

(1.8)

2.4

(13.1)

Established Pharmaceuticals

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,382

1,046

336

Total reported

1,382

1,046

336

% Change vs. 4Q24

U.S.

n/a

n/a

n/a

International

9.0

10.3

5.0

Total reported

9.0

10.3

5.0

Impact of foreign exchange

2.0

1.6

3.1

Organic

7.0

8.7

1.9

U.S.

n/a

n/a

n/a

International

7.0

8.7

1.9

Established Pharmaceuticals sales increased 9.0 percent on a reported basis and 7.0 percent on an organic basis in the fourth quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 10.3 percent on a reported basis and 8.7 percent on an organic basis, led by double-digit growth in India and several countries across Latin America and the Middle East.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

5,536

4,167

1,369

Total reported

5,536

4,167

1,369

% Change vs. 12M24

U.S.

n/a

n/a

n/a

International

6.6

8.0

2.5

Total reported

6.6

8.0

2.5

Impact of foreign exchange

(0.8)

(1.5)

1.1

Organic

7.4

9.5

1.4

U.S.

n/a

n/a

n/a

International

7.4

9.5

1.4

Medical Devices

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,605

340

340

283

287

304

208

843

International

3,070

365

390

92

496

371

66

1,290

Total reported

5,675

705

730

375

783

675

274

2,133

% Change vs. 4Q24

U.S.

10.7

12.8

13.1

11.7

6.5

4.8

1.9

14.9

International

13.7

13.4

13.9

17.9

8.9

16.3

23.8

14.2

Total reported

12.3

13.1

13.5

13.2

8.0

10.8

6.5

14.5

Impact of foreign exchange

1.9

1.6

1.0

1.1

1.5

2.1

0.9

2.8

Organic

10.4

11.5

12.5

12.1

6.5

8.7

5.6

11.7

U.S.

10.7

12.8

13.1

11.7

6.5

4.8

1.9

14.9

International

10.1

10.2

11.9

13.4

6.6

12.3

19.6

9.6

Worldwide Medical Devices sales increased 12.3 percent on a reported basis and 10.4 percent on an organic basis in the fourth quarter.

Sales growth in the quarter was led by double-digit growth in Electrophysiology, Heart Failure, Diabetes Care, and Rhythm Management.

In Diabetes Care, sales of continuous glucose monitors were $2.0 billion and grew 15.0 percent on a reported basis and 12.2 percent on an organic basis.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

9,968

1,334

1,283

1,107

1,118

1,172

773

3,181

International

11,419

1,315

1,481

341

1,877

1,351

237

4,817

Total reported

21,387

2,649

2,764

1,448

2,995

2,523

1,010

7,998

% Change vs. 12M24

U.S.

13.4

15.7

12.4

12.2

5.8

11.5

0.8

20.8

International

12.0

6.4

11.7

16.4

5.4

13.0

21.5

15.4

Total reported

12.6

10.9

12.0

13.2

5.6

12.3

5.0

17.5

Impact of foreign exchange

0.7

0.7

0.4

0.5

0.5

0.8

0.2

1.2

Organic

11.9

10.2

11.6

12.7

5.1

11.5

4.8

16.3

U.S.

13.4

15.7

12.4

12.2

5.8

11.5

0.8

20.8

International

10.5

5.0

10.9

14.3

4.7

11.5

20.5

13.5

(Press release, Abbott, JAN 22, 2026, View Source [SID1234662161])

On January 22, 2026 Ellipses Pharma Limited ("Ellipses"), a clinical-stage oncology drug development company with a pipeline of innovative programmes, reported that it has entered into a collaboration and licence agreement with Innolake Biopharm Co. Ltd ("Innolake") to develop a clinical stage first-in-class antibody drug conjugate (ADC).

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Under the partnership, Ellipses gains rights to develop a B7H3 targeted ADC with an eribulin payload (ILB-3101) worldwide excluding greater China. ILB-3101 has the potential to treat multiple tumour types and to address resistance to topoisomerase-1 based ADCs. ILB-3101 is designated as EP0028 by Ellipses.

Ellipses and Innolake will collaborate closely on the development of ILB-3101/EP0028, which is currently in a Phase 1 trial in China sponsored by Innolake. Ellipses will initiate a Phase 1 clinical trial in the US with expansion to Europe and other territories following relevant regulatory approvals.

EP0028 is an important addition to Ellipses’ clinical-stage pipeline and is the second programme Ellipses has in-licensed from an innovative biotech company based in China. The first programme, EP0031, is a next-generation selective RET inhibitor developed by Kelun Biotech, which Ellipses is currently advancing through Phase 2 trials.

Professor Sir Chris Evans, OBE, Executive Chair of Ellipses, commented: "We are delighted to bring this differentiated ADC into our pipeline. EP0028 has the potential to address unmet needs in a range of indications and further strengthens our strategy to develop Chinese originated assets in the West."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer of Ellipses, commented: "Ellipses’ decision to in-license EP0028 is a significant milestone for us in continuing our mission to develop new cancer drugs for patients with high unmet clinical needs. Our collaboration with Innolake is another great opportunity to develop innovative cancer drugs globally, robustly and at speed to serve our communities."

Mingde Xia, CEO of Innolake, commented: "This partnership is a great validation of our technology and capabilities. Having advanced ILB-3101 from early discovery through to the clinic, we are delighted to collaborate with Ellipses and look forward to bringing this innovative therapy to patients worldwide."

(Press release, Ellipses Pharma, JAN 22, 2026, View Source [SID1234662177])

On January 22, 2026 Daiichi Sankyo reported that ENHERTU (trastuzumab deruxtecan) has been approved in China 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 one prior trastuzumab based regimen. ENHERTU previously received conditional approval for third-line or later treatment based on laterline phase 2 data.

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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).

More than one third of the global cases of gastric cancer occur in China, with about 65% of patients presenting with advanced disease at the time of diagnosis.1,2,3 Approximately 359,000 cases of gastric cancer and 260,000 deaths were reported in China in 2022.1 About one in five gastric cancers are considered HER2 positive. 4,5 Prior to the results of DESTINY-Gastric04, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.

The approval of ENHERTU by China’s National Medical Products Administration (NMPA) is based on results from the DESTINY-Gastric04 phase 3 trial presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine. The China Center for Drug Evaluation (CDE) granted Breakthrough Therapy Designation for ENHERTU for the second-line gastric cancer indication in 2020 due to efficacy data from early trials and the unmet clinical need. ENHERTU also was granted Priority Review by the CDE in this setting, enabling approval in China in approximately six months.

In DESTINY-Gastric04, ENHERTU demonstrated a 30% reduction in risk of death compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive unresectable and/or metastatic gastric or GEJ adenocarcinoma (hazard ratio [HR]: 0.70; confidence interval [CI]: 0.55-0.90; p=0.0044). Median overall survival (OS) was 14.7 months with ENHERTU (n=246; 95% CI: 12.1-16.6) compared to 11.4 months with ramucirumab plus paclitaxel (n=248; 95% CI: 9.9-15.5).

In the secondary endpoint analysis of progression-free survival (PFS), ENHERTU demonstrated a 26% reduction in the risk of disease progression or death versus ramucirumab plus paclitaxel (HR: 0.74; 95% CI: 0.59-0.92; p=0.0074) as assessed by investigator. Median PFS was 6.7 months (95% CI: 5.6-7.1) with ENHERTU versus 5.6 months (95% CI: 4.9-5.8) with ramucirumab plus paclitaxel. A confirmed objective response rate (ORR) of 44.3% (95% CI: 37.8-50.9) was seen in patients treated with ENHERTU with seven complete responses (CR) and 97 partial responses (PR) versus a confirmed ORR of 29.1% (95% CI: 23.4- 35.3) with three CRs and 66 PRs in the ramucirumab plus paclitaxel arm (p=0.0006). Median duration of response (DOR) was 7.4 months (95% CI: 5.7-10.1) in the ENHERTU arm and 5.3 months (95% CI: 4.1- 5.7) in the ramucirumab plus paclitaxel arm.

"Most patients with gastric cancer are diagnosed with advanced disease, which has a low survival rate and is particularly challenging to treat," said Lin Shen, MD, Director of the Department of Gastrointestinal Oncology, Peking University Cancer Hospital and lead investigator of the DESTINY-Gastric04 trial in China. "This approval is an important milestone for the clinical community in China, addressing a critical gap in second-line targeted therapy for HER2 positive gastric cancer. This development is driving a paradigm shift from chemotherapy towards precision therapy in the second-line setting for patients with HER2 positive gastric cancer. At the same time, it provides clinicians with a powerful new option capable of significantly extending patient survival. We will be able to bring this innovative treatment to earlier lines of therapy, benefit a broader patient population, improve long-term outcomes and achieve longer survival."

"This sixth approval for ENHERTU in China in less than three years fully demonstrates the potential of this innovative medicine to make significant contributions in clinical practice," said Michio Hayashi, China President, Daiichi Sankyo. "DESTINY-Gastric04 is the first randomized phase 3 trial ever to show a survival benefit in the second-line HER2 positive metastatic gastric cancer setting and also confirmed the results of the DESTINY-Gastric01 and DESTINY-Gastric06 trials."

"ENHERTU is already established in China in the third-line or later treatment setting for patients with HER2 positive metastatic gastric cancer and this approval brings this important medicine to an earlier line of therapy," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "This latest approval in China underscores our commitment to bringing ENHERTU to patients in earlier treatment settings to improve outcomes and expand the number of people who may benefit."

The safety profile of ENHERTU in DESTINY-Gastric04 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or grade 4 adverse reactions from a pooled safety population receiving at least one dose of ENHERTU 6.4 mg/kg (n=1,133) across multiple tumor types in clinical studies were nausea (64.3%), fatigue (57.3%), anemia (47.9%), decreased appetite (46.8%), neutropenia (45.9%), vomiting (34.7%), diarrhea (33.0%), thrombocytopenia (32.9%), leukopenia (31.2%), alopecia (29.0%), constipation (28.2%) and increased transaminases (26.4%). Grade 5 adverse reactions occurred in 2.2% of patients, including interstitial lung disease (ILD; 1.6%). Discontinuation of treatment due to an adverse reaction occurred in 13.2% of patients. The most frequent adverse reaction associated with permanent discontinuation was ILD (9.8%).

ENHERTU also is being evaluated as a potential first-line treatment for HER2 positive metastatic gastric cancer through two ongoing phase 3 trials – DESTINY-Gastric05 and ARTEMIDE-Gastric01.

About DESTINY-Gastric04

DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint is OS. Secondary endpoints include investigator-assessed PFS, ORR, DOR, disease control rate and safety.

In March 2025, an Independent Data Monitoring Committee recommended unblinding DESTINY-Gastric04 based on the superior efficacy of ENHERTU seen at a planned interim analysis.

DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancerrelated death, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.2,7 Approximately one million cases of gastric cancer were diagnosed in 2022.

Incidence rates for gastric cancer are markedly higher in eastern Asia, particularly in China where more than one third of all global cases occur. 1,2 Gastric cancer is the fifth most common cancer in China with about 359,000 new cases diagnosed in 2022.1 Additionally, it is the third leading cause of cancer-related death in China, with approximately 260,000 deaths reported in 2022.1 Approximately 65% of patients in China present with advanced disease at the time of diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.8 Approximately one in five gastric cancers are considered HER2 positive. 4,5 Recommended first-line treatment in China for HER2 positive advanced or metastatic gastric cancer is combination chemotherapy and trastuzumab, an anti-HER2 medicine, with or without pembrolizumab. 9 For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, subsequent anti-HER2 treatment options are limited.

Prior to the results of the DESTINY-Gastric04 trial of ENHERTU, no other HER2 directed medicine had demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.

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 (IHC 3+ or 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 (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 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 and/or DESTINY-Gastric04 trials.

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 22, 2026, View Source [SID1234665023])