ImmunityBio Reports Positive Phase 2 Results for Chemotherapy-Free Brain Cancer Therapy; Sanofi Advances Global Filing of Amlitelimab Following Successful Phase 3 Trials

Chemotherapy-Free Treatment for Brain Cancer: Positive Phase 2 Results of Innovative Therapy Announced

ImmunityBio today announced the latest data from the QUILT-3.078 Phase 2 clinical study, which is evaluating a chemotherapy-free immunotherapy regimen combining the IL-15 superagonist Anktiva (nogapendekin alfa inbakicept) with CAR-NK cell therapy for the treatment of patients with recurrent or progressive glioblastoma (GBM) in the second-line setting, also including first-line to third-line patients treated under single-patient INDs (spINDs). As of January 22, 2026, the study has enrolled 23 GBM patients who experienced recurrence or progression after standard treatments (including surgery, radiation, and temozolomide chemotherapy), with 19 still alive. The primary endpoint of the study is overall survival (OS).As of the data update, the median overall survival has not yet been reached, suggesting that this regimen demonstrates potential benefits in extending survival.

Among the 14 evaluable patients, the longest overall survival observed from the time of disease recurrence has reached 12 months, and follow-up is still ongoing.Notably, the average absolute lymphocyte count (ALC) of these patients at enrollment was only 0.9×10³/μL, severe lymphocytopenia was confirmed, but the ALC significantly increased to ≥1.4×10³/ within one treatment cycle.μL (p<0.001, N=14). The study showed,Anktiva in combination with CAR-NK therapy can help maintain immune function, with statistically significant improvements observed compared to baseline in all assessments during follow-up to 20 weeks (p≤0.026).In terms of safety, the regimen has demonstrated manageable safety characteristics after a cumulative total of 219 administrations to date. Among the 41 patients enrolled in QUILT-3.078 and spINDs, only three serious adverse events related to treatment were reported.

Latest Results of Two Phase 3 Trials Announced, Sanofi to Advance Global Launch of Monoclonal Antibody

Sanofi today announced the latest results of the Phase 3 clinical studies SHORE and COAST 2, supporting the potential of its OX40 ligand (OX40L) targeted monoclonal antibody amlitelimab for treating patients aged 12 years and older with moderate to severe atopic dermatitis (AD).Sanofi said,Based on all the research data, the companyWill advance the global regulatory submission for amlitelimab.

The analysis showed that in the SHORE study,Amlitelimab Combined with Topical Therapy Achieved All Primary and Key Secondary Endpoints at Week 24, with Efficacy Continuously Improving Throughout the Treatment Period; Some Patients Showed Signs of Improvement as Early as Week 2.

▲SHORE Trial Primary Endpoint Results (Image Source: Reference [1])

The primary endpoint results of the COAST 2 study are as follows. The press release noted that this result further confirms the potential for once every 12 weeks dosing (Q12W) from the initial stage, as previously suggested in the COAST 1 study.

▲COAST 2 Trial Primary Endpoint Results (Image Source: Reference [1])

In these two Phase 3 studies, amlitelimab was generally well-tolerated, with a safety profile consistent with previously reported data. Additionally, preliminary analysis of the Phase 2 ATLANTIS clinical study showed that the treatment maintained sustained, progressive improvement through Week 52 without evidence of a plateau in efficacy.

References:

[1] Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis. Retrieved January 23, 2026 from https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400

[2] ImmunityBio Reports Median Overall Survival Not Yet Reached and Lymphopenia Reversed in Recurrent Glioblastoma Patients Receiving ANKTIVA® Plus CAR-NK, Chemo-Free Therapy. Retrieved January 23, 2026 from https://www.businesswire.com/news/home/20260123454593/en/ImmunityBio-Reports-Median-Overall-Survival-Not-Yet-Reached-and-Lymphopenia-Reversed-in-Recurrent-Glioblastoma-Patients-Receiving-ANKTIVA-Plus-CAR-NK-Chemo-Free-Therapy

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