The American Society for Clinical Oncology (ASCO) meeting in 2026, a cornerstone event for oncological advancements, has concluded, leaving behind a vast repository of data for the global medical community to meticulously analyze. Among the most compelling revelations were the emerging successes of novel cell therapy approaches, particularly in vivo cell therapies, which demonstrated considerable potential in combating both hematological malignancies and solid tumors. This surge in promising data validates significant strategic investments, most notably Eli Lilly and Company’s impending $7 billion acquisition of Kelonia Therapeutics, signaling a potential paradigm shift in cancer treatment.
Lilly’s Strategic Investment in Kelonia Therapeutics Appears Poised for Substantial Returns
Eli Lilly’s substantial investment in Kelonia Therapeutics, announced in April 2026, is already demonstrating its strategic foresight. The acquisition, valued at up to $7 billion with an upfront payment of $3.25 billion, hinges on Kelonia’s pioneering work in in vivo cell therapy. Initial data presented at ASCO 2026 for Kelonia’s lead candidate, KLN-1010, a in vivo CAR-T therapy, showcased remarkable efficacy in patients battling multiple myeloma.
The Phase I inMMyCAR trial (NCT07075185) reported an impressive 100% overall response rate (ORR) among the 18 evaluable patients, with all achieving minimal residual disease (MRD)-negative bone marrow within one month of treatment. This is a critical benchmark, indicating the eradication of even the smallest traces of cancer that could lead to relapse. The durability of this response is further underscored by the fact that the first patient treated remains in a deep, ongoing MRD-negative remission for over 10 months. Among the six patients with more than four months of follow-up, four attained stringent complete response (sCR), a complete disappearance of cancer and restoration of normal blood counts, while two achieved very good partial response (VGPR), demonstrating significant reduction in cancer. Crucially, all these patients maintained MRD-negative bone marrow.
A key differentiator of KLN-1010 is its ability to elicit robust and sustained generation of CAR-T cells within the patient’s peripheral blood and bone marrow. This in vivo approach contrasts with traditional ex vivo CAR-T therapies, which require the patient’s T-cells to be collected, genetically engineered in a laboratory, and then reinfused. The observed persistence of CAR-T cells in vivo suggests a potentially more durable and less burdensome therapeutic option.
Regarding safety, the inMMyCAR trial reported a favorable profile. While 16 out of 18 patients experienced cytokine release syndrome (CRS), a common and potentially serious side effect of CAR-T therapies, all events were classified as Grade 1-2 in severity, indicating manageable symptoms. Furthermore, one Grade 1 and one Grade 3 immune effector-cell-associated neurotoxicity syndrome (ICANS) event were noted, which are also being closely monitored.
Professor Joy Ho of the Royal Prince Alfred Hospital, Sydney, Australia, and an investigator in the inMMyCAR trial, commented on the promising early findings. "Early data from Kelonia’s lead in vivo CAR-T programme continues to demonstrate highly encouraging responses in additional patients, with the benefit of extended follow-up revealing a consistent pattern of strong clinical responses over time, and a continued favorable safety profile," Professor Ho stated. "The persistent generation of CAR-T cells observed across the expanded cohort reinforces the potential of KLN-1010 to make a meaningful difference for multiple myeloma patients." The ongoing nature of the acquisition and the positive clinical data suggest that Lilly’s strategic acquisition is well-positioned to capitalize on the burgeoning in vivo cell therapy market.
Strand Therapeutics’ Preclinical In Vivo Platform Shows Transformative Potential for Solid Tumors
Complementing the clinical advancements in multiple myeloma, Strand Therapeutics also presented compelling preclinical data at ASCO 2026, highlighting the promise of its in vivo approach for solid tumors. Following a substantial $135 million funding round last year, Strand Therapeutics showcased data demonstrating the efficacy of its programmable EverScript circular RNA (circRNA) technology, delivered via targeted lipid nanoparticles (LNPs). This innovative combination has proven capable of generating functional CAR-T cells in vivo following intravenous administration. The preclinical studies in humanized mouse models and non-human primates (NHPs) achieved robust target cell elimination, a critical hurdle in treating aggressive solid tumors.
Strand’s initial program, STX-001, which involves intratumoral delivery of an LNP-encapsulated self-replicating RNA expressing IL-12, has already provided preliminary evidence of systemic immune activation and anti-tumor activity in patients with advanced solid tumors who had exhausted prior treatment options. Building on this early clinical validation, the intravenously delivered STX-003 is engineered for precise tumor-targeted expression and aims to mitigate off-target effects.
Dr. Jake Becraft, co-founder and CEO of Strand Therapeutics, emphasized the significance of these findings. "Generating functional CAR-T cells inside the body has been a long-standing goal for the field, and the data show we can do it with delivery precision and programmable safety controls it requires," Dr. Becraft remarked. " In vivo CAR-T is a natural extension of what we have been building, and the NHP data is exactly the kind of validation that moves this program forward." The successful demonstration of in vivo CAR-T generation in NHPs, a more complex biological system, represents a significant leap forward and suggests a strong translational potential for this technology in treating a wide range of solid tumors.
Immunocore Selects Phase III Dose for Brenetafusp, Further Validating In Vivo Therapy
Adding to the momentum of in vivo therapeutic advancements, Immunocore Holdings presented encouraging Phase I data for its ImmTAC (Immune-mobilising monoclonal T-cell Receptor Against Cancer) therapy, brenetafusp, also classified as an in vivo therapy. The Phase I/II study (NCT04262466) investigated brenetafusp in patients with heavily pretreated advanced melanoma, a notoriously aggressive skin cancer.
In the cohort of 66 patients treated with brenetafusp monotherapy, the median overall survival (OS) was 14.3 months. The OS rates at six and 12 months were 87% and 57%, respectively, indicating a substantial impact on patient longevity. The disease control rate (DCR), which measures the proportion of patients whose cancer did not progress, was 52%, while the overall response rate (ORR) stood at 12%.
The data revealed that the 160 mcg dose of brenetafusp exhibited the most promising clinical activity. This dose has now been selected for evaluation in an ongoing Phase III trial (NCT06112314). This pivotal trial will compare brenetafusp in combination with Opdivo (nivolumab), a widely used immunotherapy, against standard Opdivo regimens in patients receiving first-line treatment for advanced melanoma. This strategic move by Immunocore to advance brenetafusp into a Phase III trial underscores the confidence in its efficacy and the potential for it to become a new standard of care.
The safety profile of brenetafusp was generally well-tolerated, demonstrating a predictable, mechanism-driven safety profile both as a monotherapy and in combination with other agents. The most frequently observed treatment-related adverse events (TRAEs) included CRS, rash, pyrexia (fever), chills, fatigue, decreased lymphocyte count, nausea, and pruritus (itching). These side effects are largely consistent with those seen with other immune-based therapies.
Professor Georgina Long, Medical Director of the Melanoma Institute Australia at the University of Sydney, commented on the significance of these findings for melanoma patients. "Patients with advanced melanoma who progress on anti-PD-1 therapy have limited options, and seeing meaningful disease control in heavily pretreated patients is genuinely promising," Professor Long stated. "These results support continued evaluation of brenetafusp in advanced melanoma." The progression of brenetafusp to Phase III trials signifies a critical step towards potential regulatory approval and broader patient access.
The Ascendance of In Vivo Cell Therapies: A New Era in Oncology?
The collective data presented at ASCO 2026 strongly suggests that in vivo cell therapies are rapidly evolving from a theoretical concept to a clinically viable therapeutic modality. The ability to engineer the body’s own immune cells to target and destroy cancer cells directly within the patient offers several potential advantages over existing treatments. These include the possibility of simplified manufacturing processes, reduced patient burden, and potentially more durable and widespread anti-tumor responses.
The successes of Kelonia Therapeutics, Strand Therapeutics, and Immunocore at this premier oncology conference are not isolated incidents but rather indicators of a broader trend. The pharmaceutical industry, recognizing this potential, is increasingly investing in companies and technologies that facilitate in vivo cellular reprogramming. Lilly’s substantial acquisition of Kelonia is a clear testament to this industry-wide recognition of the transformative power of in vivo approaches.
The ongoing development and clinical evaluation of these therapies hold immense promise for patients battling a wide spectrum of cancers, from hematological malignancies like multiple myeloma to challenging solid tumors. As research progresses and more data emerges from ongoing trials, in vivo cell therapies are poised to play an increasingly central role in the future of cancer treatment, offering new hope and improved outcomes for patients worldwide. The convergence of innovative delivery systems, advanced genetic engineering techniques, and a deeper understanding of tumor immunology is propelling this exciting field forward at an unprecedented pace.
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