Onco-Summaries: Daily Oncology Updates at a Glance
11/09/2026
Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules (Ref)
Handa Pharmaceuticals has received final US FDA approval for OMCAZIO™ (cabozantinib; multikinase inhibitor) capsules, transitioning from tentative approval to full authorization for US commercialization
OMCAZIO is a laurylsulfate salt version of cabozantinib that can be taken with or without food, eliminating fasting restrictions
Approved Indications:
Advanced renal cell carcinoma (RCC), alone or with nivolumab
Hepatocellular carcinoma (HCC) after sorafenib
Adult/pediatric patients (≥12 years) with previously treated, unresectable, locally advanced or metastatic extra-pancreatic neuroendocrine tumors (epNET)
OMCAZIO is supplied in 34.5 mg, 23 mg, and 11.5 mg capsule strengths
Immutep refocuses eftilagimod alfa development on PD-L1-negative (CPS <1) HNSCC and neoadjuvant STS following TACTI-004 discontinuation (Ref)
Immutep announced that future registration-directed development of eftilagimod alfa (efti; soluble LAG-3 protein) is intended to focus on first-line recurrent or metastatic with negative PD-L1 expression (CPS <1) and on the neoadjuvant setting of soft tissue sarcoma (STS)
The decision follows the discontinuation of the Ph3 TACTI-004 trial in first-line in Mar 2026, after a planned interim futility analysis
Immutep's ongoing root cause analysis has identified structural differences between the efti used in TACTI-004 and the efti used in earlier successful clinical studies
TACTI-004 used efti manufactured exclusively at 2,000 L scale. Earlier Ph1 and Ph2 studies that Immutep describes as successful, including TACTI-mel, TACTI-002 and INSIGHT-003, used ten GMP batches manufactured at 200 L scale
Immutep considers these differences, such as a subtle difference in N-glycan structure, potentially relevant given the markedly different immune activation profile and the unexpected clinical outcome in TACTI-004
According to Immutep, neither clinical factors (such as a suboptimal protocol, a substantial imbalance between treatment arms or safety findings) nor trial execution factors (such as an invalid randomization pattern or general trial conduct) explain the outcome
The analysis continues, including investigation of smaller differences between product batches. Immutep has contracted a new efti manufacturing run at 200 L scale and has not given a completion date
Next steps
Preparations for the next clinical trials have commenced, with study start targeted for 2H CY2027
The start date remains subject to final decisions on trial design, regulatory interactions, manufacturing timelines, partnering and resources
Immutep describes this focus as a staged risk/benefit approach, consistent with prior FDA interactions, the FDA Orphan Drug Designation for STS (Apr 2026) and the Fast Track designation
SERENA-4 Phase 3 trial of Etcamah + palbociclib missed its primary PFS endpoint in 1L ER+/ HER2- advanced breast cancer (Ref)
AstraZeneca reported Phase 3, SERENA-4/ NCT04711252 results evaluating Etcamah (camizestrant; an oral SERD) + palbociclib (CDK4/6 inhibitor) as 1L treatment for ER+/HER2- advanced breast cancer.
The trial did not demonstrate a statistically significant PFS benefit, although a numerical improvement was observed
The safety profile was consistent with the known safety profiles of each medicine, with no new safety concerns identified
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