The Targeted Pulse: FDA Approvals in HCC and CRC, Promise for SCLC, and More
The week marked several FDA approvals for drugs and devices, plus data continues to show tarlatamab’s benefit in small cell lung cancer.
FDA Greenlights Potent Nivolumab/Ipilimumab Combo for First-Line Use
The FDA granted approval for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for adults with unresectable hepatocellular carcinoma (HCC). This decision is supported by findings from the phase 3 CheckMate 9DW (NCT04039607) clinical trial.
In this study, 668 patients with unresectable HCC who had not received prior systemic therapy were randomized to receive either the nivolumab and ipilimumab combination or the investigator's choice of standard treatments. The results demonstrated a statistically significant improvement in median overall survival (OS) for patients receiving the combination therapy (23.7 months) compared with those receiving lenvatinib (Lenvima) or sorafenib (Nexavar; 20.6 months). The 24-month OS rates were 49% and 39%, respectively. For more details, access the full article here.
FDA Approves Dual Immunotherapy for Frontline MSI-H/dMMR Colorectal Cancer
The FDA also approved the nivolumab plus ipilimumab for the first-line treatment of adult and pediatric patients aged 12 and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC). Alongside this, the FDA granted regular approval to nivolumab monotherapy for previously treated patients in this same group, converting its prior accelerated approval.
These decisions are supported by the phase 3 CheckMate-8HW (NCT04008030) trial. Results showed the nivolumab/ipilimumab combination significantly improved progression-free survival (PFS) compared with chemotherapy in the first-line setting. Median PFS was not reached with the combination vs 5.8 months with chemotherapy.
The trial also compared the combination against nivolumab monotherapy across all lines of treatment, finding superior PFS and a higher objective response rate (ORR) for the combination.
Experts note this dual immunotherapy addresses an unmet need for patients with this aggressive form of CRC. For more details, access the full article here.
Tarlatamab Shows Overwhelming Survival Benefit
The phase 3 DeLLphi-304 (NCT03319940) trial demonstrated that tarlatamab-dlle (Imdelltra) significantly improved OS compared with standard-of-care chemotherapy in patients with small cell lung cancer (SCLC) that progressed after 1 line of platinum-based chemotherapy. This positive result met the trial's primary end point at a planned interim analysis. The safety profile of tarlatamab was consistent with previous findings.
These topline results from the global, randomized study, which enrolled 509 patients with SCLC, suggest a substantial clinical benefit and potentially establish tarlatamab as a new standard in this setting.
Tarlatamab, a bispecific T-cell engager, was previously granted accelerated approval by the FDA in May 2024 for this patient population based on earlier phase 2 data.
For more information, access the full article here.
Next-Gen IORT: ZEISS INTRABEAM 700 Gains FDA Clearance
The ZEISS INTRABEAM 700 received FDA 510(k) clearance for enhanced intraoperative radiation therapy (IORT). This next-generation platform combines robotic precision, a digital-first workflow, and integrated connectivity, making it valuable for oncologic surgeons, particularly in neuro-oncology and breast cancer.
The system delivers robotic-assisted precision, enhancing control during IORT. Its SMART Stand allows for seamless transitions between approach and navigation modes, managed via touch controls. Precise applicator positioning, active vibration damping, and dynamic stabilization ensure consistent radiation delivery.
The INTRABEAM 700 emphasizes efficiency with single-use applicators, RFID-assisted management, and a user-friendly interface. Integrated Radiance™ software enables real-time radiation planning, improving preoperative assessment and intraoperative confidence. The system also integrates into surgical infrastructure and hospital information systems. Several clinical trials are investigating the INTRABEAM platform.
For the full story, access the article here.
Larotrectinib Receives Full FDA Approval Following Promising Trial Results
Larotrectinib (Vitrakvi) has received full FDA approval for adult and pediatric patients with solid tumors that have an NTRK gene fusion, lack known acquired resistance, are metastatic or where surgery would cause severe morbidity, and lack alternative treatments or have progressed after prior therapy.
This approval is based on data from 3 open-label, single-arm trials. An analysis of 339 patients with unresectable or metastatic solid tumors harboring an NTRK gene fusion showed an ORR of 60%, with a complete response rate of 24%. The median duration of response was 43.3 months.
The full approval follows an earlier accelerated approval in November 2018. For more information, access the full article here.
Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.
In case you missed it, here is last week’s Targeted Pulse.
