Cadonilimab plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma: a step forward for bispecific immunotherapy?
Editorial Commentary

Cadonilimab plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma: a step forward for bispecific immunotherapy?

Jia Li Low1 ORCID logo, Lu Lu Huang2 ORCID logo, Boon Cher Goh1,3,4

1Department of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore; 2Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China; 3Department of Pharmacology, National University of Singapore, Singapore, Singapore; 4Cancer Science Institute of Singapore, National University of Singapore, Singapore, Singapore

Correspondence to: Boon Cher Goh, MBBS. Department of Haematology-Oncology, National University Cancer Institute, 5 Lower Kent Ridge Road, Singapore 119074, Singapore; Department of Pharmacology, National University of Singapore, Singapore, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore, Singapore. Email: phcgbc@nus.edu.sg.

Comment on: Jiang Y, Bei W, Wang L, et al. Efficacy and safety of cadonilimab (PD-1/CTLA-4 bispecific) in combination with chemotherapy in anti- PD-1-resistant recurrent or metastatic nasopharyngeal carcinoma: a single-arm, open-label, phase 2 trial. BMC Med 2025;23:152.

Keywords: Nasopharyngeal carcinoma (NPC); bispecific antibodies (BsAbs); programmed death-ligand 1 (PD-L1); cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)

Submitted Oct 13, 2025. Accepted for publication Dec 17, 2025. Published online Feb 04, 2026.

doi: 10.21037/cco-2025-aw-130

Introduction

Recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) remains a therapeutic challenge despite significant advances in systemic therapy over the past decade. NPC is an endemic cancer in Southeast Asia and North Africa, presenting with late-stage disease and propensity for local recurrence in the head and neck region or distant metastases. There is a strong association with Epstein-Barr virus (EBV) in tumour cells, where the EBV genome is episomal and expression of type 2 latency EBV genes like LMP1, LMP2, and EBNA1 is thought to promote carcinogenesis. Within the tumour microenvironment (TME) of NPC, immunohistochemistry studies show frequent prominence of lymphocytic infiltrates, high programmed death-ligand 1 (PD-L1) expression, the presence of several immune targets such as CD40, CD70, CD80, and CD86, as well as expression of EBV antigens (1-3). The landscape of NPC TME is also characterised by antigenic stimulation, prominence of T cell exhaustion, and presence of immune regulatory cells. Accordingly, there is a strong biological rationale for the incorporation of immune checkpoint inhibitors (ICIs) (4).

The integration of ICIs into the first-line setting—notably programmed cell death protein 1 (PD-1) inhibitors combined with gemcitabine and cisplatin (GP)—has transformed the management of advanced NPC, yielding objective response rates (ORRs) generally higher than chemotherapy alone [79% for toripalimab-GP, 87% for camrelizumab-GP,70% for tislelizumab-GP, 81.7% for tagitanlimab (KL-A167)-GP (4)], and superior median progression-free survival (PFS) compared to chemotherapy alone [21.4 months for toripalimab, 9.7 months for camrelizumab, 9.6 months for tislelizumab, not reached for tagitanlimab, and 9.6 months for penpulimab-kcqx (5)] in pivotal phase III trials [CAPTAIN-1st, RATIONALE-309, JUPITER-02, KL167-III-08 (NCT05294172), and Study AK105-304 (NCT04974398)]. Though not the primary endpoint, overall survival (OS) was prolonged by the addition of anti-PD-1 to chemotherapy in the toripalimab study (52% OS at 5 years). Yet, over 40% of patients ultimately experience disease progression within 2 years, and therapeutic options beyond platinum-based chemotherapy and PD-1 failure remain unsatisfactory, with reported ORR of only 20–34% and PFS around 4–7 months with standard later-line therapies. The median survival ranges from 7 to 11 months in these patients (6). Therefore, there is an unmet clinical need to develop effective therapy for an increasing population of patients who fail first-line chemoimmunotherapy as these regimens become standard of care.

Immunotherapy after first-line platinum-based chemotherapy

In another population of patients who have received standard platinum-based chemotherapy, who are treatment naïve to anti-PD-1 axis inhibitors, KEYNOTE-122 demonstrated that anti-PD-1 immunotherapy monotherapy is not superior to single-agent physician’s choice chemotherapy of either single-agent docetaxel, gemcitabine, or capecitabine (7), underscoring the modest clinical activity of monotherapy with anti-PD-1 antibodies in RM-NPC. Most phase 2 clinical trials of anti-PD-1 treatment alone in platinum-resistant NPC patients report ORR ~20–25%.

In this group of platinum-experienced patients, promising immunotherapy combinations have emerged. Combination therapy with nivolumab (anti-PD-1) and ipilimumab [anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4)] leverages on mobilising peripheral effector T-cells while reducing intratumoral regulatory T cells (Tregs). This mechanism is highly relevant in NPC, which is characteristically enriched with tumour-infiltrating lymphocytes, including CD8+ cytotoxic T cells, CD4+ helper T cells, and a substantial population of CTLA-4 expressing immunosuppressive FOXP3+ Tregs. In a single-arm phase 2 trial of ipilimumab with nivolumab, Lim et al. reported that ipilimumab 1 mg/kg every 6 weeks combined with nivolumab 3 mg/kg every 3 weeks achieved an ORR was 37%, with a median PFS of 5.3 months in 40 patients with prior chemotherapy treated, immunotherapy naïve patients (8). This trial does not answer whether the addition of anti-CTLA-4 to anti-PD-1 therapy overcomes tumour immune evasion after anti-PD-1 treatment.

Other combination checkpoint inhibitors are being explored in NPC. For instance, LAG3 and TIM3 have been found as markers of T cell exhaustion in NPC (9). Therefore, a clinical trial evaluating the immunotherapy combination of an anti-LAG3 LBL 007 and toripalimab in RM-NPC showed ORR of 33.3% in immunotherapy naïve patients with a promising median PFS of 10.8 months (10). Another trial of combining anti-PD-1 antibody penpulimab and anti-TIM3 antibody TQB2618 is in progress (NCT05563480). Relatlimab, an anti-LAG3 monoclonal antibody approved for metastatic melanoma in combination with nivolumab, is also being evaluated as maintenance therapy in first-line RM-NPC when combined with nivolumab in a randomised study after initial treatment with cisplatin, gemcitabine, and nivolumab.

An alternative promising chemotherapy-free immunotherapy strategy in platinum-resistant RM-NPC has been to combine anti-PD-1 therapy with anti-angiogenic agents such as bevacizumab. The rationale lies in vascular normalization, overcoming endothelial cell anergy, improving immune infiltration, and counteracting vascular endothelial growth factor (VEGF)-driven immunosuppression. To prove this, a randomised phase 2 trial showed a more than four-fold improvement in ORR of the combination compared to pembrolizumab monotherapy (11).

Immunotherapy combinations after first-line platinum-based chemotherapy and anti-PD-1 immunotherapy

In the population of patients who have progressed on anti-PD-1 immunotherapy, the response to rechallenge anti-PD-1 therapy in NPC is unknown but expected to be low, and whether primary anti-PD-1 resistance or secondary failure (initial response to anti-PD-1 treatment but subsequent progression) makes a difference is uncertain. However, recently several strategies to overcome immunotherapy failure offer hope.

Combination with antiangiogenic agents has demonstrated tumour response after progression with anti-PD-1 treatment. In a phase 2 clinical trial of camrelizumab and apatinib [VEGF receptor (VEGFR) small molecule inhibitor] in RM-NPC, two cohorts of patients were evaluated. In the prior anti-PD-1 treated cohort, 32 patients were treated, and the primary endpoint of ORR was 34.3% [95% confidence interval (CI): 17–51.8%] (12). In the randomised phase 2 trial of pembrolizumab with or without bevacizumab in platinum-resistant NPC patients, 13 patients crossed over from the pembrolizumab monotherapy arm to receive bevacizumab, and the ORR was 38% (11). These preliminary data suggest that the VEGF axis is an important target for immunotherapy resistance, which should be studied further.

Inhibition of PD-1/PD-L1 axis and other immune checkpoints known to be active in NPC, like LAG3, are being clinically evaluated as exemplified by a phase 1b clinical trial of toripalimab (anti-PD-1) and LBL-007 (anti-LAG3) in RM-NPC, demonstrating 11.8% ORR in immunotherapy-experienced patients with an interesting median duration of response of 13.5 months (10) (Table 1).

Table 1

Clinical trials of immunotherapy combinations in patients with RM-NPC after failure of anti-PD-1 therapy

Study Agent(s) Phase Number Patient population ORR (95% CI), % PFS (95% CI), months OS (95% CI), months Grade 3 or more TRAEs Treatment-related DR/discontinuation rate
Chong et al. (11) Camrelizumab, apatinib 2, single arm, open label 25 Prior anti-PD-1 34.3 (17–51.8) 4.5 (3.7–5.4) 16.2 (13.1–NR) Hypertension (27.8%), hand-foot syndrome (12.5%), AST increase (11.1%) 68.1%/4.2%
Gong et al. (9) Toripalimab, anti-LAG3 antibody LBL-007 1b/2, single arm, open label 30 Progression after standard therapies IO-naïve: 33.3 (9.9–65.1); IO-treated: 11.8 (1.5–36.4) IO-naïve: 10.8 (1.3–NR); IO-treated: 2.7 (1.4–4.9) – Anaemia (2.5%), hyponatremia (2.5%), increased alanine aminotransferase (2.5%), increased aspartate amino transferase (1.3%), and fatigue (1.3%) –/8.8%
Jiang et al. (13) Camrelizumab, famitinib 2, open label 18 Progression after platinum chemotherapy and anti-PD-(L)1 33.3 (15.6–55.4) 7.2 (90% CI: 4.4–13.3) 12-month OS: 87.7 44.4%. Thrombocytopenia (22.2%), neutropenia (11.1%), hand foot syndrome (11.1%), nasopharyngeal necrosis (11.1%) 27.8%/27.8%
Chen et al. (10) Pembrolizumab with or without bevacizumab 2, randomised, open label 48 (13 crossed over from pembrolizumab > pembrolizumab/bevacizumab) Platinum resistant, IO naïve Crossover arm (post-hoc analysis): 38% Crossover arm (post-hoc analysis): 5 (2.8–NR) – Thrombosis/bleeding (17%), hypertension (4%), proteinuria (4%) –/18.8%

AST, aspartate aminotransferase; CI, confidence interval; DR, dose reduction; IO, immunotherapy; NR, not reached; ORR, overall response rate; OS, overall survival; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; RM-NPC, recurrent or metastatic nasopharyngeal carcinoma; TRAEs, treatment-related adverse events.

Emergence of bispecific antibodies (BsAbs)

Given this slew of options of combined immunotherapy strategies post anti-PD-1 progression in NPC (Table 2), the emergence of BsAb engineering may contribute additional benefit. BsAbs are antibody constructs engineered to target two antigenic epitopes with a single antibody. They can achieve a variety of therapeutic mechanisms through the various targeted antigens and by altering their structure. Targeting two antigen targets has received considerable attention in novel cancer therapeutics. By simultaneous dual target engagement, these BsAbs can redirect T cells to cancer cells [bispecific T-cell engagers (BiTEs)] through CD3 binding on one antigen binding epitope and another membrane-bound antigen expressed on cancer cells. Binding to two antigens via variable portions [single-chain variable fragments (scFvs)] that are expressed on cancer cell membranes allows two signalling pathways to be inhibited simultaneously and more effectively.

Table 2

Clinical trials of BsAbs in development in patients with NPC

Patient population Title Status Clinical Trials.gov identifier
Local regionally advanced NPC Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma Not yet recruiting NCT07064902
Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE) (GEMSTONE) Not yet recruiting NCT05587374
Metastatic NPC A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Completed NCT04220307
Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma Not yet recruiting NCT05898256
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (PDL1x41BB) Terminated NCT03809624
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (DUET-3) Completed NCT03752398
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (DUET-4) Completed NCT03849469
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (DUET-2) Completed NCT03517488

BsAbs, bispecific antibodies; NPC, nasopharyngeal carcinoma.

Retention of the Fc portion of the antibodies can be leveraged to enhance immune activation via antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ACP), and improve pharmacokinetic half-life for a longer duration of action. Removal of the Fc portion can reduce ADCC in antibodies that bind to effector immune cells to abrogate the elimination of these cells. Some immunotherapeutic BsAB have agonist and antagonist activity, for example, PDL1xOx40 or PDL1x4-1-BB to co-stimulate the appropriate receptors to activate an effective immune response. Here, through deft engineering of differential-affinity BsAbs, one arm binds strongly to a broader expressed but safe antigen expressed preferentially in the TME (e.g., PD-L1, HER2) while the other agonist arm (e.g., CD28, 4-1-BB, Ox40) has reduced affinity, such that meaningful activation occurs only when both epitopes are engaged in cis on the same cell or within the tumour. This theoretically enhances immune cell recruitment into the TME for antitumour activity, and reduces risks of drug resistance and tumour progression compared to monotherapy alone (14).

Examples of BiTEs and dual pathway blockade antibodies in non-hematologic malignancies include tarlatamab and amivantamab. Tarlatamab, an anti-DLL3-CD3 BiTE targeting delta-like ligand 3 that has high membrane expression in small cell lung cancer (SCLC) compared to normal lung tissue, is effective in recurrent metastatic SCLC beyond chemotherapy and immunotherapy. In a phase 2 study of tarlatamab in SCLC patients that had prior chemotherapy treatment, an ORR of 40% and OS of 14.3 months (15). A subsequent phase 3 study comparing tarlatamab against chemotherapy of topotecan, lurbinectedin, or amrubicin in second-line treatment of SCLC with progression after platinum-based chemotherapy showed superior median OS [13.6 vs. 8.3 months; hazard ratio (HR) =0.6; 95% CI: 0.47 to 0.77] (16). Amivantamab is a BsAb with dual targeting of cMET and epidermal growth factor receptor (EGFR) and has efficacy in lung cancers harbouring EGFR_exon20 insertion mutations (17).

Cadonilimab in RM-NPC after failure of chemoimmunotherapy

The development of cadonilimab, a BsAb targeting PD-1 and CTLA-4, is aimed at dual targeting to enhance immune activation within the tumour. It has a tetravalent structure that binds with avidity to both antigens and crosslinks cells expressing these antigens without the Fc portion of antibodies, therefore reducing ADCC, CDC, and cytokine release and potentially render it safer than separate PD-1 and CTLA-4 combined blockade with separate antibodies. Leveraging on these characteristics, more effective T cell activation in the TME is achieved while reducing systemic CTLA-4 activation and immunotoxicity. Phase 1 studies have reported its tolerability.

In a recent single-arm phase 2 study, cadonilimab was combined with TPC chemotherapy (nab-paclitaxel, cisplatin or lobaplatin, and capecitabine) in RM-NPC who have failed at least 1 line of chemotherapy and anti-PD-1 therapy. These patients are usually treated with salvage chemotherapy or enrolled in clinical trials. While single-agent chemotherapy after platinum failure has an ORR of 23% in KEYNOTE-122 (7), combination chemotherapy achieves generally higher response rates of up to 68% with TPC (13). The response to rechallenge anti-PD-1 therapy in NPC is unknown but expected to be low, and whether primary anti-PD-1 failure or secondary failure makes a difference is uncertain. However, recently several strategies to overcome immunotherapy failure offer hope. Combination with antiangiogenic agents has demonstrated tumour response after progression with anti-PD-1 treatment. Inhibition of PD-1/PD-L1 axis and other immune checkpoints known to be active in NPC, like LAG3, are being clinically evaluated as exemplified by a phase 1b clinical trial of toripalimab (anti-PD-1) and LBL-007 (anti-LAG3) in RM-NPC, demonstrating 11.8% ORR in immunotherapy-experienced patients with an interesting median duration of response of 13.5 months (10). In this context, cadonilimab combined with TPC had an ORR of 68% and a median PFS of 10.6 months, with manageable toxicities. In particular, severe grade 3 or higher immune-related adverse events (IrAEs) appeared less frequently compared with ipilimumab/nivolumab.

It should be noted that this trial is to be interpreted as preliminary, given the potential for patient selection bias in an open-label non-randomised study. Furthermore, it does not address the efficacy of combination PD-1 and CTLA-4 checkpoint blockade in anti-PD-1 progression, as effective chemotherapy was part of the regimen. Relevant to this is the monotherapy treatment of chemotherapy-treated patients with RM-NPC, where cadonilimab monotherapy showed an ORR of 26% and a median PFS of 3.7 months (18), which is comparable to anti-PD-1 treatment alone and ipilimumab/nivolumab combination. Future studies should include translational studies to assess proof of mechanism of potent PD-1 and CTLA-4 inhibition in the TME and evaluate potential predictive biomarkers of clinical benefit in these patients. For example, longitudinal tumour sampling with treatment may reveal increased immune infiltration with effector T and B cells or depletion of immunosuppressive Tregs, myeloid-derived suppressor cells, which have been correlated with immunotherapy response. Randomised clinical trials to compare chemotherapy with or without cadonilimab in PD-1 resistant RM-NPC are awaited. These findings warrant comparison with other strategies such as ipilimumab/nivolumab or pembrolizumab/bevacizumab.

In conclusion, the work of Jiang et al. provides early evidence that BsAbs like cadonilimab can effectively break through the barrier of immunotherapy resistance in NPC. By simultaneously targeting PD-1 and CTLA-4 with a single, ingeniously engineered molecule, promising tumour responses were achieved with chemotherapy in NPC with favourable safety profile. If these findings are confirmed in randomized trials, cadonilimab combined with chemotherapy could be a treatment for patients with anti-PD-1-resistant RM-NPC, representing a shift in the therapeutic sequence of this challenging disease.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Chinese Clinical Oncology. The article has undergone external peer review.

Peer Review File: Available at https://cco.amegroups.com/article/view/10.21037/cco-2025-aw-130/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cco.amegroups.com/article/view/10.21037/cco-2025-aw-130/coif). J.L.L. receives consulting fees, conference funding from AstraZeneca, and honorarium from DKSH and Top Alliance Bioscience. B.C.G. received research grant support from Merck Sharp and Dohme and is supported by research funding from the National Medical Research Council of Singapore (under grant No. NMRC/STaR/MOH-00070900). B.C.G. also served on the advisory boards of BeOne and MSD. The other author has no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Low JL, Huang LL, Goh BC. Cadonilimab plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma: a step forward for bispecific immunotherapy? Chin Clin Oncol 2026;15(1):19. doi: 10.21037/cco-2025-aw-130

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