Cancer Immunotherapy in 2025: A Systematic Review of Clinical Effectiveness, Safety, and Real-World Outcomes

By Editorial Team

Executive Summary

Cancer immunotherapy represents one of the most consequential paradigm shifts in oncology since the advent of combination chemotherapy [1–3]. By targeting immune checkpoints, tumor antigens, or immune effector cells themselves, immunotherapies have delivered durable, and in some cases curative, responses in a subset of patients across historically lethal malignancies [4–7].

However, population-level benefit remains heterogeneous. Immune checkpoint inhibitors (ICIs) consistently extend survival in several cancers, although absolute overall survival (OS) gains are often modest at a population level.

Many regulatory approvals rely on surrogate endpoints rather than mature overall survival (OS) data [32,35], immune-related toxicities can be severe or permanent [28–30], and costs place substantial strain on healthcare systems [38–40]. Real-world effectiveness frequently diverges from pivotal trial results [54].

Credit: Statista

1. Introduction

1.1 Historical Context

The foundations of cancer immunotherapy lie in immune surveillance and immunoediting theory [1,2]. Modern clinical translation accelerated following the discovery of immune checkpoints and the approval of ipilimumab in metastatic melanoma, which demonstrated an OS benefit for the first time in this disease [3,4].

Since 2011, immune checkpoint inhibitors (ICIs) have expanded rapidly across tumor types, representing more than half of oncology drug approvals in recent years [48,49].

1.2 Rationale for a Systematic Review

Hundreds of studies on immunotherapy and cancer are available in the National Library of Medicine. This article is a work in progress, systematically compiling related studies as a living evidence hub for immunotherapy.

Despite rapid adoption, critical questions remain unresolved:

  • What are the absolute OS gains across indications? [33]

  • Which biomarkers meaningfully predict benefit? [16]

  • How durable are responses in real-world populations? [54]

  • Are costs proportionate to clinical value? [38, 56]

2. Methods

2.1 Review Framework

This white paper applies PRISMA-aligned principles for systematic narrative synthesis [32].

2.2 Data Sources

Evidence was drawn from randomized controlled trials [4–15], meta-analyses, real-world datasets [54], and regulatory assessments [48,49].

2.3 Inclusion and Exclusion Criteria

Studies involving adult cancer populations treated with FDA- or EMA-approved immunotherapies and reporting survival, response, quality of life, or safety outcomes were included [48]. Preclinical studies and single-arm case reports without context were excluded.

3. Classes of Cancer Immunotherapy

3.1 Immune Checkpoint Inhibitors (ICIs)

ICIs targeting PD-1, PD-L1, and CTLA-4 restore antitumor T-cell activity [3]. Landmark trials demonstrated OS benefits in melanoma, NSCLC, renal cell carcinoma (RCC), and Hodgkin lymphoma [4–15].

Across unselected populations, median OS gains are typically modest (2–6 months), with durable long-term survival observed in approximately 10–30% of patients [7,33].

3.2 Adoptive Cell Therapies

CAR‑T cells and TIL therapies have shown high efficacy in hematologic cancers and emerging proof of concept in solid tumors, such as gastric or gastroesophageal cancers where patients lived ~40% longer in recent trials (The Guardian 2025). However, toxicity and logistical complexity remain barriers, and solid tumor efficacy is limited [20,24].

3.3 Cancer Vaccines

Cancer vaccines generate robust immune responses but have demonstrated limited survival benefit as monotherapy [25,26]. Current development focuses on combination strategies with ICIs.

3.4 Cytokine Therapies

High-dose IL-2 and interferon therapies established early proof-of-concept for immune-mediated tumor regression but are now rarely used due to narrow therapeutic indices [27].

4. Clinical Effectiveness by Cancer Type

4.1 Melanoma

Melanoma represents the strongest clinical success of immunotherapy, with 5-year survival exceeding 50% in selected patients receiving combination PD-1/CTLA-4 blockade [6,7]. Durable responses may persist after treatment discontinuation.

4.2 Non–Small Cell Lung Cancer (NSCLC)

ICIs improve OS in PD‑L1 high expressers and in combination with chemotherapy. Real‑world data indicate reduced effectiveness in older patients and those with poor performance status, compared to pivotal trials. (Springer 2025) 

4.3 Small Cell Lung Cancer (NSCLC)

Chemoimmunotherapy combinations demonstrate OS and PFS improvements compared with chemo alone in extensive‑stage SCLC, although benefit sizes vary by study. PubMed (2024)

4.4 Renal Cell Carcinoma (RCC)

Combination ICI–ICI or ICI–TKI regimens improve OS compared with sunitinib but increase toxicity burden [13–15].

4.4 Colorectal Cancer (CRC)

In MSI‑high/dMMR CRC, ICIs deliver significant survival gains in both trials and real‑world settings. In microsatellite‑stable CRC, combination regimens show mixed results with ongoing study. Springer (2025)

4.5 Other Solid Tumors

Emerging evidence suggests benefit in hepatocellular carcinoma and esophageal cancers as neoadjuvant or conversion therapy, though larger randomized studies are pending. Springer (2025)

5. Biomarkers and Patient Selection

PD-L1 expression, MSI/dMMR status, and tumor mutational burden (TMB) are the most widely used biomarkers, though each has significant limitations [16]. Emerging biomarkers include immune gene signatures and gut microbiome composition [46–47]. No single biomarker reliably predicts benefit across tumor types.

6. Safety and Immune-Related Adverse Events

Immune-related adverse events (irAEs) range from mild endocrinopathies to life-threatening myocarditis and pneumonitis [28–30]. Real-world data indicate higher incidence and severity of irAEs than reported in trials.

7. Quality of Life

Quality-of-life improvements are primarily confined to durable responders [31]. Non-responders may experience net harm due to toxicity without survival gain [35]. Long-term patient-reported outcome data remain limited.

8. Resistance Mechanisms

Resistance to immunotherapy arises from an immune‑exclusion tumor microenvironment, antigen loss, and adaptive escape mechanisms. Advanced multi‑omic models are identifying complex resistance patterns that could inform future precision strategies. arXiv (2025)

9. Health Economics and Policy Implications

Annual costs frequently exceed USD 100,000 per patient [38,39]. Cost-effectiveness depends heavily on the proportion of long-term survivors, raising concerns about value-based reimbursement and accelerated approvals without confirmatory benefit [32].

10. Recent and Real‑World Developments in 2025

  • A late‑stage lung cancer immunotherapy combo recently failed to improve OS despite good tolerability, illustrating ongoing challenges in overcoming resistance. Reuters

  • Real‑world observational studies confirm that ICI benefits in NSCLC are generally consistent with trial data but vary by patient subgroup. PubMed

  • CAR‑T therapy for solid tumors showed promising OS and PFS improvements in early randomized data, signaling potential expansion beyond hematologic diseases. The Guardian

11. Discussion

Immunotherapy provides transformative benefit for a minority of patients but modest average benefit for most [33]. Overreliance on surrogate endpoints risks overstating value and exposing patients to toxicity without clear survival advantage. Precision application and long-term follow-up are essential.

12. Future Directions

Future advances hinge on:

  • Personalized immunotherapy platforms, including neoantigen‑based strategies.

  • Microbiome modulation and combination therapy optimization.

  • Adaptive clinical trial designs that account for delayed treatment effects and real‑world heterogeneity.

  • Continued integration of genomic and multi‑omic resistance models into clinical decision tools. arXiv (2025)

13. Conclusions

Cancer immunotherapy in 2025 remains a powerful modality with life‑extending potential for many patients but also important limitations. Its optimal role lies in biomarker‑guided use, transparent outcome reporting, and alignment of regulatory approvals with meaningful patient‑centric benefits.

References

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