ImmunityBio Updates Phase 2 Clinical Results from QUILT 3.078
ImmunityBio announced updated Phase 2 clinical results from QUILT 3.078, evaluating a chemotherapy-free combination immunotherapy regimen in patients with second-line recurrent or progressive glioblastoma, as well as patients treated under single-patient INDs across first- to third-line disease. Primary endpoint of QUILT-3.078 is overall survival; median overall survival has not yet been reached, with 19 of 23 enrolled patients alive as of January 22. Fourteen patients have evaluable data, with the longest survival from time of disease recurrence reaching 12 months to date and ongoing. Baseline mean absolute lymphocyte count among these 14 patients was 0.9 x 103/uL, confirming severe lymphopenia at enrollment. ALC increased within one treatment cycle, with mean ALC rising to greater than or equal to 1.4 x 103/uL. Immune competence was maintained, with statistically significant increases from baseline observed at all assessments through 20 weeks with Anktiva + CAR-NK ANKTIVA + CAR-NK demonstrated a manageable safety profile following a total of 219 doses administered to date, with three treatment-related serious adverse events reported among 41 GBM patients enrolled across QUILT-3.078 and single-patient INDs. Randomized controlled trials in both first line and second line glioblastoma are in development.
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Oncolytics Biotech Strengthens Leadership Amid Oncology Market Surge
- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical response rate of 6-11%, demonstrating significant efficacy in this difficult-to-treat population.
- FDA Alignment Success: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
- Strategic Expansion: The company has also expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, aiming to accelerate clinical development across multiple indications and enhance overall R&D capabilities.

Oncolytics Biotech Strengthens Leadership to Advance Clinical Programs
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.






