The FDA is evaluating sunvozertinib (DZD9008) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease has progressed following platinum-based chemotherapy. This regulatory review follows promising results from the phase 2 WU-KONG1 trial (NCT03974022).
Sunvozertinib Shows Promise in EGFR-Mutated NSCLC
In the WU-KONG1 trial, sunvozertinib demonstrated a best overall response rate (ORR) of 53.3% (97.5% CI, 42.0%-64.3%) and a confirmed ORR of 44.9% (97.5% CI, 34.0%-56.1%). These findings suggest that sunvozertinib could offer a significant clinical benefit for patients with EGFR exon 20 insertion mutations who have limited treatment options after progressing on platinum-based chemotherapy. Sunvozertinib was previously approved in China for the same indication in August 2023.
CAR-T Therapy Approved for B-ALL
Obecabtagene autoleucel (obe-cel; Aucatzyl), a CD19-directed autologous CAR T-cell therapy, has received FDA approval for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from the phase 1/2 FELIX trial (NCT04404660), which showed a complete remission (CR) rate of 42% (95% CI, 29%-54%) within 3 months of infusion among evaluable patients (n = 65). The median duration of CR for those who responded within 3 months was 14.1 months (95% CI, 6.1–not reached).
NCCN Guidelines Updated for CLL/SLL
Recent revisions to the National Comprehensive Cancer Network (NCCN) guidelines for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) include the addition of venetoclax (Venclexta) plus obinutuzumab (Gazyva) as a preferred regimen in later-line settings for patients with and without 17p deletions/TP53 mutations. Additionally, lisocabtagene maraleucel (Breyanzi) has been included as the first CAR T-cell therapy approved for CLL.
