On May 22, 2026 AstraZeneca and Daiichi Sankyo reproted that Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Programme, Memorial Sloan Kettering Cancer Centre and investigator for TROPION-Breast02, said: "Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients."

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: "For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: "As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients. With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types."

In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

This application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China and Japan.

Based on the results of TROPION-Breast02, datopotamab deruxtecan (Datroway) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 Preferred 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines for detailed recommendations.2

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately 11,000 patients with TNBC receive treatment in the 1st-line setting each year.5-7 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.8-10 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,11,12

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.8 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.8 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.13,14 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the only approved 1st-line treatment.15

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.16 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.17,18

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase III trial and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

(Press release, AstraZeneca, MAY 22, 2026, View Source [SID1234666003])

On May 22, 2026 The Parker Institute for Cancer Immunotherapy (PICI) reported that research and expertise from across its network will be on prominent display throughout the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2. PICI leaders, investigators, and collaborators are contributing to more than 50 oral sessions, posters, and publications — a presence that reflects the breadth, urgency, and clinical momentum of the network’s contributions to cancer immunotherapy.

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The work spans from foundational discovery to practice-changing trials, including new data in glioblastoma, melanoma, prostate, breast, lung, and urothelial cancers; updated readouts on CAR T-cell and TIL-based therapies; personalized neoantigen vaccine strategies; and immune profiling platforms that aim to predict who will benefit from checkpoint inhibition.

Adding to this strong presence, PICI will unveil the latest results from its RADIOHEAD pan-cancer cohort, with new multimodal immunoprofiling data leveraging foundation models of the immune system to predict immunotherapy response and toxicity — building on the data that PICI featured at AACR (Free AACR Whitepaper) earlier this year.

PICI will also announce the inaugural recipient of the Conquer Cancer PICI Endowed Young Investigator Award this year, to recognize an outstanding early-career clinical oncology investigator as they transition from fellowship training to faculty appointments.

"Cancer continues to demand urgency, and the PICI Network is designed to meet that challenge through coordinated, collaborative science," said Dr. Karen Knudsen, CEO of PICI. "Our participation at ASCO (Free ASCO Whitepaper) 2026 reflects the strength of this model, bringing together researchers and investigators to translate discoveries into meaningful progress for patients."

Presentation Highlights from the Network

Gliobastoma

Glioblastoma remains one of oncology’s most difficult challenges, and the PICI Network is bringing data this year that build directly on the encouraging signals shared at ASCO (Free ASCO Whitepaper) 2025.

University of Pennsylvania (Carl June, MD, Director of the PICI Center at Penn; Donald O’Rourke, MD): Updated overall survival, safety, and neurologic function outcomes from a Phase 1 trial of a bivalent CAR T-cell therapy in recurrent glioblastoma (Abstract 2013, oral session).
Dana-Farber Cancer Institute (Catherine J. Wu, MD; Patrick Ott, MD, PhD): A personalized neoantigen vaccine designed to reprogram the immune landscape of glioblastoma (Abstract 2006, oral session) — a continuation of PICI’s long-standing commitment to neoantigen-based strategies in CNS cancers.
Massachusetts General Hospital (Marcela Maus, MD, PhD): Rituximab pre-conditioning in the Phase 1 INCIPIENT trial of CARv3-TEAM-E for recurrent glioblastoma (Abstract 2059) — extending the CARv3-TEAM-E program that PICI has supported through earlier readouts.
Melanoma

TrioMBM (Allison Betof, MD, PhD — Stanford): A multicenter Phase 2 trial of relatlimab, nivolumab, and ipilimumab in patients with asymptomatic and symptomatic melanoma brain metastases (Abstract TPS9604, lead author).
OBX-115 TIL Therapy (Allison Betof, MD, PhD — Stanford): Phase 2 results of engineered tumor-infiltrating lymphocyte cell therapy with regulatable membrane-bound IL-15 in advanced melanoma after ICI progression (Abstract 9507, oral session).
STAMP (Jedd Wolchok, MD, PhD — Weill Cornell Medicine): Updated outcomes from ECOG-ACRIN EA6174 evaluating adjuvant pembrolizumab in surgically treated Merkel cell carcinoma (Abstract LBA9505, late-breaking oral co-author).
RELATIVITY-047 (F. Stephen Hodi, MD — Dana-Farber): A five-year update of nivolumab plus relatlimab in advanced melanoma (Abstract 9532), alongside a long-term indirect treatment comparison versus nivolumab plus ipilimumab (Abstract 9530).
Botensilimab ± Balstilimab (Patrick Ott, MD, PhD — Dana-Farber): Phase 2 results in patients with advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 ± CTLA-4 (Abstract 9543).
Prostate Cancer

RiboX (Karen Knudsen, MBA, PhD — PICI): A randomized Phase Ib/II study of enzalutamide with and without ribociclib in patients with RB-retaining metastatic castration-resistant prostate cancer (Abstract 5057).
CHAMP (Ana Aparicio, MD — MD Anderson): A Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive-variant metastatic prostate cancer (Abstract 5016, oral co-author).
ENZAMET Correlatives (Eli Van Allen, MD — Dana-Farber): Germline genetic correlates in metastatic hormone-sensitive prostate cancer treated with ADT plus a non-steroidal anti-androgen or enzalutamide (Abstract 5099).
C3NIRA (Padmanee Sharma, MD, PhD; Sangeeta Goswami, MD, PhD; Ana Aparicio, MD — MD Anderson): Single-cell data on early chemo-induced tumor microenvironment alterations as a predictor of response to PD-1 blockade in aggressive-variant prostate cancer (Abstract 5065).
Breast Cancer

P-RAD (TBCRC-053) (Elizabeth Mittendorf, MD, PhD — Dana-Farber): Primary results from the triple-negative cohort of a randomized trial of no-, low-, or high-dose preoperative radiation with pembrolizumab and chemotherapy in node-positive breast cancer (Abstract 1011, oral co-author).
Post-NCIT Outcomes (Elizabeth Mittendorf, MD, PhD — Dana-Farber): Outcomes after recurrence on neoadjuvant chemo-immunotherapy in patients with high-risk early-stage triple-negative breast cancer (Abstract 601, oral co-author).
ASPRIA (Elizabeth Mittendorf, MD, PhD — Dana-Farber): A single-arm Phase 2 trial of atezolizumab with sacituzumab govitecan to prevent recurrence in triple-negative breast cancer (Abstract TPS644).
Lung & Urothelial Cancers

RICHIS (Jonathan Villena-Vargas, MD — Weill Cornell Medicine): A randomized multicenter Phase 2 trial of radioimmunotherapy versus chemoimmunotherapy followed by surgery for c-stage IB–III non–small cell lung cancer (Abstract TPW8132, lead author).
Urothelial ctDNA Dynamics (Sangeeta Goswami, MD, PhD — MD Anderson): Circulating tumor DNA dynamics as an early biomarker of response to enfortumab vedotin plus pembrolizumab in advanced urothelial carcinoma (Abstract 4582).
Macrophage Polarization in Urothelial Cancer (Nina Bhardwaj, MD, PhD — Icahn Mount Sinai): The CXCL9:SPP1 ratio as a predictor of outcomes with pembrolizumab or enfortumab vedotin plus pembrolizumab in metastatic urothelial cancer (Abstract 4573).
Translational Platforms & Immune Profiling

RADIOHEAD (John Connolly, PhD — PICI): Multimodal immunoprofiling of peripheral blood using foundation models of the immune system for predicting immunotherapy response and toxicity in the RADIOHEAD pan-cancer cohort (Abstract 2533).
CTX-8371 (Patrick Ott, MD, PhD — Dana-Farber): Phase 1 dose escalation of a novel PD-1 × PD-L1 bispecific antibody in patients with advanced malignancies post checkpoint inhibition (Abstract 2629).
Axi-Cel Real-World Outcomes (David Miklos, MD, PhD — Stanford): Long-term real-world outcomes of axicabtagene ciloleucel in relapsed/refractory large B-cell lymphoma (Abstract 7028).

(Press release, Parker Institute for Cancer Immunotherapy, MAY 22, 2026, View Source [SID1234666019])

On May 22, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This recommendation, which also includes KEYTRUDA SC [known as KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026.

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"Patients in Europe with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy have limited treatment options and are at high risk for disease recurrence," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "This positive CHMP recommendation brings us closer to a new chapter of patient care – one that could address this significant unmet need by offering a KEYTRUDA-based regimen both before and after surgery, based on the compelling results from KEYNOTE-905."

The recommendation is based on results from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. The KEYTRUDA plus Padcev regimen reduced the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p<0.0001) versus surgery alone. Median EFS was not reached [NR] (95% CI, 37.3-NR) for the KEYTRUDA plus Padcev regimen versus 15.7 months (95% CI, 10.3-20.5) for surgery alone. KEYTRUDA plus Padcev also reduced the risk of death by 50% (HR=0.50 [95% CI, 0.33-0.74]; p=0.0002) versus surgery alone. Median OS was not reached (95% CI, NR-NR) for the KEYTRUDA plus Padcev regimen versus 41.7 months (95% CI, 31.8-NR) for surgery alone. The trial demonstrated a statistically significant difference in pCR rate (57.1% [95% CI: 49.3, 64.6] vs. 8.6% [95% CI: 4.9, 13.8]; p<0.0001). Results from the trial were presented during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 and published in The New England Journal of Medicine.

In November 2025, KEYTRUDA and KEYTRUDA QLEX in combination with Padcev were approved by the U.S. Food and Drug Administration (FDA), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy.

About bladder cancer

In 2022, bladder cancer changed the lives of more than 600,000 people around the world. In Europe, it is estimated there were approximately 224,700 patients diagnosed with bladder cancer and more than 70,300 deaths from the disease in 2022. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

(Press release, Merck & Co, MAY 22, 2026, View Source [SID1234666004])

On May 22, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported the preliminary PoC clinical study results for its global first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

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This study is the first stage of a PoC clinical study conducted in China, to evaluate the safety, efficacy, and dose optimization strategy of IBI363 in combination with platinum-based doublet chemotherapy (PDC) in previously untreated patients with locally advanced or metastatic NSCLC. During dose optimization, patients with NSCLC expressing PD-L1 TPS < 50% (including TPS 1-49% and TPS < 1%) were enrolled to explore the potential of IBI363 in PD-L1 negative and low-expressing NSCLC, an area with significant unmet clinical need.

The preliminary results showed that IBI363 combined with PDC demonstrated encouraging efficacy signals in the first-line treatment of NSCLC with PD-L1 negative or low expression. The 3→1.5 mg/kg dosing regimen brought comprehensive benefits with strong objective response rate (ORR), disease control rate (DCR), and manageable safety and tolerability. Meanwhile, the approach supports continuous dosing, which has the potential to translate into durable efficacy benefits with ongoing follow-up. The second stage of this study is currently ongoing, designed as a randomized head-to-head trial comparing this dose regimen vs. pembrolizumab plus chemotherapy in the first-line treatment of advanced NSCLC (all PD-L1 expression levels).

1) Mechanistic Rationale for Dosing Regimen Design and Dose Selection in Immunotherapy-naïve Population

Multiple studies have indicated that in immunotherapy (IO)-naive populations, the tumor microenvironment exhibits lower immunosuppression, which allows an immune activation strategy that ignites immunity and then maintains stability. Meanwhile, combination with chemotherapy can facilitate antigen release and activate the immune system.

Therefore, the first cycle of 3 mg/kg IBI363 could initiate the immune system to expand effector T cells rapidly, enhance T cell infiltration, and form an IO-sensitive immune microenvironment. Subsequently, a 1.5 mg/kg every three weeks (Q3W) regimen is adopted for the maintenance treatment, which could maintain the IO-sensitive tumor microenvironment, prolong the possible treatment cycles, and further enhance the efficacy. This strategy is common in the study design of other immunological treatments.

Based on this mechanism, three IBI363 combination dosing regimens were compared in the study:

3→1.5 mg/kg dose group (3 mg/kg + PDC in cycle 1, followed by 1.5 mg/kg Q3W + PDC);
1.5 mg/kg dose group (1.5 mg/kg Q3W + PDC);
3 mg/kg dose group (3 mg/kg Q3W + PDC).
2) Study Design and Baseline Characteristics: Focusing on Dose Exploration in PD-L1 Negative or Low Expression NSCLC

Previously untreated patients with locally advanced or metastatic NSCLC, without sensitizing EGFR, ALK, or ROS1 alterations were enrolled in this study. The aim of the study is to evaluate the efficacy and safety of different doses of IBI363 combined with PDC in patients with PD-L1 negative or low expression NSCLC.

As of the data cutoff date, Dec 22, 2025, a total of 80 patients had been enrolled in this Phase 1 study, including 11 patients enrolled in the safety lead-in phase and 69 patients in the dose optimization phase. The median follow-up time was 5.8 months (range: 0.9–9.5 months).

The median age was 64 years, 88.8% were male, 81.3% had an ECOG PS score of 1, and 66.3% were squamous NSCLC. The baseline characteristics of patients in the three dose groups were balanced and comparable.
In the dose optimization part, NSCLC patients with PD-L1 TPS < 50% were enrolled, of which 65.2% had PD-L1 TPS < 1% and 34.8% had TPS 1–49%.
3) IBI363 Showed Encouraging Response in First-line Treatment of PD-L1 Negative or Low Expression NSCLC

In the dose optimization stage, the 3→1.5 mg/kg dose group (n=22) showed ORR of 86.4% and confirmed ORR (cORR) of 81.8% (95% CI: 59.7-94.8) and DCR of 100%. The efficacy was consistent in the squamous (ORR 85.7%, n=14) and non-squamous (ORR 87.5%, n=8) subgroups. Additionally, durable efficacy signals were observed in the 3→1.5 mg/kg groups with ongoing follow-up. For the 1.5mg/kg (N = 19) and 3 mg/kg cohorts (N = 21), ORR was 57.9% (cORR: 42.1%) and 66.7% (cORR: 57.1%), respectively.

For NSCLC patients with negative or low PD‑L1 expression, the benefit from current immunotherapies is limited. In the Keynote‑407 study, in first‑line squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 54.5% and 67.4% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively. In the Keynote‑189 study, in first‑line non‑squamous NSCLC patients treated with PD‑1 combined with chemotherapy, the ORRs were 50.0% and 33.1% for the PD‑L1 1–49% and PD‑L1 <1% subgroups, respectively.

Previous studies have shown that, regardless of PD‑L1 expression status, IBI363 demonstrates potent anti‑tumor activity in immunotherapy‑resistant NSCLC, suggesting that its unique mechanism of action may not depend on PD‑L1 expression. Preliminary efficacy data in this study showed impressive response rate of IBI363 in combination with PDC in first-line treatment of NSCLC with PD-L1 negative or low expression. This further validates IBI363 as a PD-1/IL-2α-bias bispecific fusion protein capable of exerting potent anti-tumor effects regardless of PD-L1 expression status, underscoring the powerful immune-activating effects of IL-2.

4) Favorable Safety Supports Continuous Administration with Potential to Translate into Long-term Efficacy Benefits

Good safety and tolerability were observed in 3→1.5 mg/kg dose groups. Among all patients, grade ≥3 treatment-related adverse events (G3+ TEAEs) were occurred in 65.2% of patients in the 3→1.5 mg/kg dose group, which was lower than the 3 mg/kg dose group (93.1%) and the 1.5 mg/kg dose group (82.1%). This favorable safety supports 3→1.5 mg/kg as the recommended dose regimen for further clinical investigation of IBI363 in combination therapies as a first-line treatment of NSCLC, which has the potential to translate into durable efficacy benefits.

The most common treatment emergent adverse events (TEAEs) among all patients were anemia (any grade: 78.8%; grade ≥3: 18.8%), neutrophil count decrease (75.0%; 42.5%), white blood cell count decrease (63.8%; 20.0%), arthralgia (51.3%; 2.5%), and platelet count decrease (45.0%; 17.5%).

5) Conclusion and follow-up:

Based on the comprehensive evaluation of preliminary efficacy and safety data, dose regimen of 3→1.5 mg/kg is the recommended dose for further clinical investigation of IBI363 combined with chemotherapy as a first-line treatment for advanced NSCLC. Currently, as the second part of the PoC study, a randomized head-to-head study of 3→1.5 mg/kg IBI363 combined with chemotherapy vs. pembrolizumab combined with chemotherapy as first-line treatment for advanced NSCLC (all PD-L1 expression levels) is ongoing.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is designed to break through the bottleneck of current immunotherapy. Data from this study demonstrate that by designing a dosing strategy consistent with its immune mechanism, IBI363 achieved an encouraging response rate, leveraging its strong advantages in effectively activating the IL-2 pathway in first-line NSCLC patients with PD-L1 negative or low expression. At the same time, its favorable safety and tolerability holds the potential to translate into long term efficacy benefits. This not only further validates the mechanism but also represents a significant step in its clinical application. We look forward to continued evaluation of IBI363 in first-line treatment of NSCLC and the accumulation of data from the ongoing head-to-head PoC study to provide further evidence for the development of IBI363."

About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 22, 2026, View Source;innovent-announces-preliminary-poc-data-of-ibi363-pd-1il-2-bias-bispecific-fusion-protein-in-combination-with-chemotherapy-as-first-line-treatment-for-advanced-nsclc-showing-encouraging-efficac-302779649.html [SID1234666020])

On May 22, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy (sacituzumab govitecan-hziy) as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy. The European Commission decision on the additional Trodelvy indication is anticipated later in 2026.

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Metastatic TNBC is an aggressive form of breast cancer that is associated with low survival rates. For many patients with metastatic TNBC, first-line therapy may be their only line of treatment, necessitating an urgency to act using the most effective treatment options first to maximize patient outcomes.

"Metastatic TNBC remains one of the most challenging breast cancer subtypes to treat, particularly at the time of first diagnosis of advanced disease, when therapeutic options are limited for many patients," said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. "The CHMP’s positive opinion for sacituzumab govitecan represents an important step towards potential approval in this setting and reflects the clinically meaningful results observed in the ASCENT-03 study. Advancing effective treatment options earlier in the disease course is critical to improving outcomes for people living with metastatic TNBC."

The CHMP’s recommendation is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication based on the ASCENT-03 study.

"This CHMP positive opinion for Trodelvy represents a pivotal moment for people with metastatic TNBC across Europe, and we look forward to hearing from the European Medicines Agency," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "Building on the extensive clinical experience with Trodelvy in later lines of therapy, this recommendation has the potential to fundamentally change how we approach treating certain first-line metastatic TNBC patients, offering a much-needed option earlier in care when it can make the greatest difference. Each step forward means more options and more chances to change the story for people living this cancer."

Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Keytruda (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. These applications are currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L mTNBC, across PD-L1 status.

Trodelvy is currently approved as a second-line plus treatment for metastatic TNBC and for patients with pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated across 60+ countries since 2020. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer (mBC).

The use of Trodelvy plus pembrolizumab in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Triple-Negative Breast Cancer

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. INDICATIONS FOR TRODELVY

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, MAY 22, 2026, View Source [SID1234666005])