NKT2152 Shows Promise in Advanced Renal Cell Carcinoma
核心洞察
NKT2152, a novel oral HIF2α (搜索) inhibitor, demonstrates encouraging objective response rates (ORR) in pretreated advanced clear cell renal cell carcinoma (搜索) (RCC (搜索)) patients.
The phase 1/2 study (NCT05119335) involving 100 RCC (搜索) patients presented at the 2024 ESMO Congress, highlights NKT2152's robust antitumor activity.
FDA has approved trastuzumab-strf (搜索) (Hercessi (搜索)) 420-mg dose for HER2 (搜索)-overexpressing cancers, expanding access to this biosimilar following the 150-mg approval.
A novel oral HIF2α (搜索) inhibitor, NKT2152, is generating excitement with promising objective response rates (ORR) in patients with previously treated advanced clear cell renal cell carcinoma (搜索) (RCC (搜索)). The data, from a phase 1/2 study (NCT05119335) involving 100 patients, were presented at the 2024 ESMO Congress.
NKT2152: A Potent HIF2α Inhibitor
NKT2152 is designed to improve pharmacokinetics and sustain target inhibition. By preventing the transcription of HIF2α (搜索)-regulated genes, it disrupts angiogenesis, glycolysis, and tumorigenesis, key processes in RCC (搜索) development.
"NKT2152 demonstrated robust antitumor activity in heavily pretreated patients with high-risk advanced clear cell RCC (搜索)," said Eric Jonasch, MD, lead study author and professor at The University of Texas MD Anderson Cancer Center. He noted a trend towards better ORR in favorable-risk disease, ECOG performance status 0, and in mTOR-naive patients.
Amivantamab Approval for EGFR-Mutated NSCLC
Amivantamab-vmjw (Rybrevant), in combination with carboplatin and pemetrexed, has received FDA approval for locally advanced or metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)) with EGFR (搜索) exon 19 deletions or exon 21 L858R substitution mutations. This approval targets patients who have progressed after EGFR tyrosine kinase inhibitor (TKI) treatment. The decision was based on the phase 3 MARIPOSA-2 trial (NCT04988295), which randomized 657 patients who had progressed on osimertinib to amivantamab/lazertinib/chemotherapy, chemotherapy alone, or amivantamab/chemotherapy.
Sanjay Popat, BSc, MBBS, FRCP, PhD, consultant medical oncologist at The Royal Marsden NHS Foundation Trust, commented on the durability of the response, stating, "Indeed, amivantamab’s multi-targeted mechanism of action and immune cell-directed activity, combined with chemotherapy’s nonspecific antitumor effects, likely contributes to this observed durability."
Trastuzumab-strf (Hercessi) Receives FDA Approval
The FDA has approved the 420-mg dose of the trastuzumab biosimilar, trastuzumab-strf (搜索) (Hercessi (搜索); formerly HLX02), for cancers with HER2 (搜索) overexpression, including metastatic breast and gastric/gastroesophageal junction cancers. This follows the earlier approval of the 150-mg dose in April, which was supported by data from a global, multicenter phase 3 trial (NCT03084237).
"The strength and success of our collaboration with Accord continues with the approval of the 420 mg strength of [trastuzumab-strf (搜索)]. This represents an important step in our journey to meet the needs of patients with innovative, high quality, and affordable therapeutics," said Jason Zhu, MD, executive director and chief executive officer of Henlius.