Cancer treatment is entering a phase in which understanding a tumour's biological behaviour can be just as important as identifying its location. Immunotherapy is contributing to this change by helping the body's immune system recognise and attack cancer cells.
As researchers investigate new treatment combinations and clinicians increasingly use molecular testing, immunotherapy market is becoming closely connected with advances in precision medicine, clinical decision-making and personalised oncology.
When a Biomarker Can Change the Treatment Plan
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One of the most important developments in immunotherapy is the growing role of biomarkers in determining which patients may benefit from particular treatments.
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Instead of relying exclusively on cancer type or stage, clinicians can examine molecular characteristics that influence how a tumour responds to immune-based medicines.
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Mismatch repair deficiency (dMMR), microsatellite instability-high (MSI-H) status and programmed death-ligand 1 (PD-L1) expression are examples of biomarkers used in specific treatment decisions.
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These characteristics can help identify patients for whom particular immunotherapies may be appropriate.
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The US Food and Drug Administration (FDA) reinforced this approach on October 16, 2026, by granting traditional approval to pembrolizumab for certain previously treated, unresectable or metastatic tumour mutational burden-high solid tumours.
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The updated indication specifies a threshold of at least 13 mutations per megabase, determined using an FDA-authorised test.
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The decision illustrates why accurate patient selection matters: evidence supporting treatment at one biomarker threshold does not automatically establish the same benefit at another.
Rectal Cancer Treatment Enters a Different Conversation
A significant development arrived on October 19, 2026, when the FDA granted accelerated approval for dostarlimab (Jemperli) as a treatment for certain adults with previously untreated, locally advanced stage II or stage III rectal cancer.
The approval applies to patients whose tumours are dMMR or MSI-H, as established by an FDA-authorised test. For eligible patients, the treatment may offer an alternative to conventional approaches involving chemotherapy, radiation and surgery.
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The FDA based its decision on interim results from the phase II AZUR-1 study, which evaluated dostarlimab in 154 patients.
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The approval remains subject to the requirements of the accelerated approval pathway, including further evidence to verify clinical benefit.
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Importantly, this development does not mean that all patients with rectal cancer can avoid surgery or other established treatments. Its relevance lies in creating another carefully defined treatment option for a particular patient population.
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Engineered Viruses Give Immunotherapy another Route
Immunotherapy is not limited to medicines that block immune checkpoints. Oncolytic viral therapies represent another approach: engineered viruses are designed to infect and destroy cancer cells while helping stimulate an immune response against the tumour.
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In August 2026, the FDA granted accelerated approval to vusolimogene oderparepvec (Tudriqev), an engineered viral therapy used with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed following a PD-1-blocking treatment regimen.
Among the 91 patients evaluated in the supporting clinical trial, 24% experienced an objective response, with a median response duration of 14.1 months.
These results highlight the clinical interest in approaches that combine different immune-based mechanisms, particularly for patients whose cancer has progressed despite previous treatment. They also demonstrate the importance of evaluating both the likelihood of a response and how long that response lasts.
Treatment Combinations Are Expanding Beyond Advanced Disease
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Another important shift is the use of immunotherapy at different points in the cancer treatment journey. Rather than reserving immune-based medicines exclusively for advanced disease, researchers and clinicians are evaluating their role before surgery, after surgery and alongside established treatments.
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For example, in October, 2026, the FDA approved atezolizumab in combination with chemotherapy for the adjuvant treatment of stage III dMMR colon cancer following complete resection of the primary tumour. The decision was supported by the ATOMIC trial, which enrolled 711 adults and one paediatric patient.
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This development demonstrates how biomarker-defined treatment strategies are extending into settings where the objective includes reducing the risk of cancer returning after surgery.
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The suitability of a particular regimen still depends on the patient's diagnosis, clinical circumstances and applicable treatment guidance.
The Patient Experience Must Remain Central
Despite scientific progress, immunotherapy requires careful monitoring. Treatments that strengthen immune activity can sometimes cause the immune system to attack healthy tissues, resulting in inflammation affecting organs such as the lungs, liver, intestines, kidneys or thyroid.
According to the National Cancer Institute, side effects vary by treatment type and individual patient. Some can emerge during treatment or after it has ended, making communication between patients and healthcare professionals essential.
For healthcare providers, this creates a practical need for clear patient education, timely symptom assessment, laboratory monitoring and coordinated specialist care. A treatment's value cannot be judged solely by its ability to shrink a tumour; tolerability, quality of life and the management of complications also matter.
What These Developments Mean for Oncology Practice?
Immunotherapy market is increasingly shaped by the relationship between biological evidence and everyday clinical decisions. Recent regulatory developments illustrate three particularly important changes:
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More precise patient selection: Molecular and biomarker testing can identify specific groups for whom particular treatments are indicated.
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A broader treatment toolkit: Checkpoint inhibitors, cellular therapies and engineered viral treatments offer different ways to engage the immune system.
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Greater attention to the complete treatment journey: Decisions increasingly consider treatment timing, previous therapies, potential complications and the patient's individual circumstances.
The central development is not simply the arrival of additional medicines. It is the growing ability to match particular therapies with the biological features of a patient's cancer. Continued clinical research, confirmatory evidence, safety monitoring and equitable access will determine how successfully these advances translate into meaningful improvements in cancer care.