The Targeted Pulse: Check Out Positive and Negative Updates in Head and Neck Cancer, and How the FDA is Handling Advancements in Lung Cancer Treatment

Post-Operative Nivolumab Redefines Standard-of-Care in Head and Neck Cancer

Nivolumab (Opdivo) improved disease-free survival in patients with resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are at high risk of relapse. In the randomized, controlled, open-label, phase 3 NIVOPOSTOP GORTEC 2018-01 trial (NCT03576417), nivolumab was added to standard-of care (SOC) radiotherapy and cisplatin after surgery and then compared with radiotherapy and cisplatin alone.

“This is the first time in decades where a therapy demonstrated superiority over SOC cisplatin-radiotherapy in patients with high-risk LA-HNSCC” said Jean Bourhis, MD, PhD, professor, principal investigator of the study and medical director of GORTEC, in a press release. To run through the trial data, visit the full article here.

Durvalumab Pales Next to Cetuximab in Advanced HNSCC

A post-hoc analysis showed that durvalumab (Imfinzi), when compared with cetuximab (Erbitux), did not improve progression-free or overall survival (OS) rates for those with locoregionally advanced HNSCC undergoing radiotherapy and with contraindications to cisplatin. These findings come from the phase 2/3 NRG-HN004 trial (NCT03258554) where 190 patients were enrolled, and 186 patients were randomly assigned 2:1 (by permuted block randomization) to either radiotherapy with durvalumab (n = 123) or radiotherapy with cetuximab (n = 63).

The trial was officially closed on September 1, 2022, and the phase 2 portion of the trial halted accrual on July 30, 2021. For a deeper dive into the study design and data, click here for the full article.

FDA Bumps Abenacianine Into the Fact Track for Lung Cancer Surgery

Injection abenacianine (VGT-309), used as an adjunct during surgery, received fast track status from the FDA. In a phase 2 efficacy study (NCT05400226), findings showed that during surgery the injected abenacianine effectively visualized primary and metastatic tumor tissue in the lung.

“Receiving fast track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said John Santini, PhD, president and chief executive officer at Vergent Bioscience, in a press release. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.” For more clarity on data and trial design, visit the full article here.

Frontline Amivantamab Plus Lazertinib Extends Life in EGFR-mutated NSCLC

Frontline amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) demonstrated significant OS improvement in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or L858R substitution mutations. In the phase 3 MARIPOSA study (NCT04487080), this combination was compared with the current SOC, osimertinib (Tagrisso). Investigators noted that median OS is expected to exceed 1 year.

“With less than 20 percent of patients living beyond 5 years, an incredible unmet need remains for [patients with] EGFR-positive lung cancer. These MARIPOSA results show [amivantamab] plus [lazertinib] can extend survival beyond the current SOC, providing patients with more time and hope in their fight against this devastating disease. Extending median OS by more than a year could be transformative for these patients,” said Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head, oncology, Johnson & Johnson Innovative Medicine, in the press release. For an extensive look into the positive data, visit the full article here.

Sunvozertinib Pockets Priority Review for EGFR-mutated NSCLC

The oral EGFR inhibitor sunvozertinib (DZD9008) received priority review status for its new drug application. The agent is indicated for the treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in patients who have experienced disease progression following platinum-based chemotherapy. The mutation had to be identified by an FDA-approved test. Findings from the phase 2 WU-KONG1 part B trial (NCT03974022) supported this submission.

“Sunvozertinib’s priority review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for [patients with] NSCLC with EGFR [exon20ins ],” said Xiaolin Zhang, PhD, chief executive officer of Dizal, in a press release. For trial design and future steps, visit the full article here.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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