The Targeted Pulse: Looking Back at 2024’s Achievements and Exploring Potential Approvals on The Horizon

Looking Back at 2024’s Top Achievements in Lung Cancers

Last year was an eventful one for transforming the treatment landscape in lung cancer with positive results leading to practice-changing approvals. Highlights include the approval of ensartinib (Ensacove) for ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) and the accelerated approval of tarlatamab-dlle (Imdelltra) for small cell lung cancer that has progressed after platinum-based chemotherapy.

In addition to approvals, this article compiles longer-term follow-up data for osimertinib (Tagrisso) in NSCLC, Oncologic Drugs Advisory Committee (ODAC) decisions, and other FDA actions that may potentially lead to new approvals in the future. To explore this recap on lung cancer in 2024, access the article here.

A One-Stop List of The FDA’s Moves During December 2024

If the holiday season was a bit of a blur, catch up on the latest FDA actions over the month of December 2024 with this full recap. The article provides a complete overview of everything that you may have missed over the holiday season. Highlights include FDA approvals for subcutaneous nivolumab (Opdivo) in adult solid tumors and for tislelizumab (Tevimbra) plus chemotherapy in first-line treatment of gastric or gastroesophageal junction cancer. To get up to speed, access the full article here.

Exploring the Unlimited Prospects of ADCs in NSCLC

During the 42nd Annual Chemotherapy Foundation Symposium® Meeting, Melissa L. Johnson, MD, took a deep dive into the unlimited potential of TROP2-directed antibody-drug conjugates (ADCs) in NSCLC. Johnson presented a deeper look into the data from the pivotal trial [TROPION- Lung01] (NCT04656652), showing progression-free survival improvement in specific subsets despite negative overall survival (OS) data.

“The sky is the limit when it comes to all these permutations. We have just begun to scratch the surface. I hope I’ve shown you the importance of patient selection in the clinical trials that we conduct,” Johnson said during the presentation. Johnson is director of lung research at Sarah Cannon Research Institute in Nashville, Tennessee. For the complete dive into these data, access the article here.

FDA Considers OS Data for Paxalisib, Indicating Path Toward Standard Approval

The FDA stated that although OS data for paxalisib (formerly GDC-0084) in glioblastoma are unsuitable for accelerated approval it could support standard approval, prompting a future pivotal trial. Secondary data from the phase 2/3 GBM-AGILE study (NCT03970447) were evaluated by the FDA in a recent Type C clinical meeting where developer Kazia Therapeutics Limited and the FDA came to an agreement on design aspects for a proposed pivotal phase 3 study.

“We believe data from the GBM-AGILE trial, including the prespecified secondary end point, which demonstrated a 3.8-month OS improvement, provides evidence supporting a clinically meaningful efficacy signal that merits further testing paxalisib in this patient population in a larger, pivotal study.” John Friend, MD, chief executive officer of Kazia, in a press release. For the full assessment of related data, access the article here.

Potential Approval Is Assessed for TLX250-CDx in ccRCC

Investigators submitted a biologics license application (BLA) for TLX250-CDx (Zircaix, ⁸⁹Zr-DFO-girentuximab), which is an investigational radiodiagnostic PET used for non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC). Findings from the phase 3 ZIRCON trial (NCT03849118), which showed no unexpected safety signals,support this BLA submission.

“We are pleased to be progressing the BLA for TLX250-CDx, which has been granted breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full US commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC,” said Kevin Richardson, chief executive officer, precision medicine at Telix, in a press release.

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.