The Targeted Pulse: NKT2152 Sparks Excitement in RCC, Amivantamab/Chemotherapy Combo Receives Approval for EGFR-Mutant NSCLC, and More

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Phase 1/2 Trial Data on NKT2152 Sparks Excitement for Advanced Kidney Cancer

A novel oral HIF2α inhibitor, NKT2152, has shown promising objective response rates (ORR) in both the overall and dose-escalation populations of patients with previously treated advanced clear cell renal cell carcinoma (RCC). These results were presented at the 2024 ESMO Congress as part of the phase 1/2 study (NCT05119335) involving 100 patients with RCC. NKT2152 is a potent HIF2α inhibitor optimized for improved pharmacokinetics and sustained target inhibition. This agent prevents the transcription of HIF2α-regulated genes essential for angiogenesis, glycolysis, and tumorigenesis.

“NKT2152 demonstrated robust antitumor activity in heavily pretreated patients with high-risk advanced clear cell RCC,” said Eric Jonasch, MD, lead study author and professor in the Department of Genitourinary Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, during a presentation of the data. “We can see a trend towards better ORR in favorable vs intermediate- and poor-risk disease, ECOG performance status 0 vs 1, and in the mTOR-naive population.”

Amivantamab/Chemotherapy Combo Now Approved For EGFR-Mutant NSCLC

Amivantamab-vmjw (Rybrevant) plus carboplatin and pemetrexed received FDA approval for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. This indication is for patients whose disease has progressed after EGFR tyrosine kinase inhibitor treatment. The approval is based on data from the phase 3 MARIPOSA-2 trial (NCT04988295) in which 657 patients who experienced disease progression on or after treatment with osimertinib (Tagrisso), were randomly assigned 1:2:2 to receive amivantamab/lazertinib/chemotherapy, chemotherapy alone, or amivantamab/chemotherapy.

“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,” Sanjay Popat, BSc, MBBS, FRCP, PhD, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research in London, said during the presentation of the data.

Navigating the Future of Acute Myeloid Leukemia With Expert Insights

In this article, Sangeetha Venugopal, MD, MS, an assistant professor of medicine in the leukemia program at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine in Florida, explores the future of acute myeloid leukemia. Venugopal discusses critical unmet needs, such as determining appropriate treatment stopping points for specific subgroups. She also shares insights on optimizing molecular testing to achieve the best patient outcomes as well as additional guidance.

“All patients must be referred for evaluation for hematopoietic cell transplant, regardless of age, because sometimes the patient’s biological age may not matter,” Venugopal explained. “Sometimes, the biological age may be lesser than the chronological age. I do think that all patients would benefit from referral for hematopoietic cell transplant.”

FDA Oks 420-mg Dose of Trastuzumab for HER2-Overexpressing Cancers

The 420-mg dose of the trastuzumab (Herceptin) biosimilar, trastuzumab-strf (Hercessi; formerly HLX02), has been approved by the FDA for cancers with HER2 overexpression, including metastatic breast and gastric/gastroesophageal junction cancers. The 150-mg dose received approval earlier this year in April, supported by data from a global, multicenter phase 3 trial (NCT03084237).

“The strength and success of our collaboration with Accord [BioPharma] continues with the approval of the 420 mg strength of [trastuzumab-strf]. 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, said in the press release.

ESMO 2024 Recap: What You Need to Know

This recap article offers a thoughtful selection of recent data presented at this year’s ESMO Congress, with links to full coverage of each presentation. It highlights key findings from various trials, including the phase 3 TiNivo-2 study (NCT04987203), the KRYSTAL-12 trial (NCT04685135), the DESTINY-Breast12 study (NCT04739761), and more. We invite you to explore this focused content for your convenience.

“Adagrasib demonstrated an improved intracranial efficacy over docetaxel in patients with treated, neurologically stable baseline brain metastases,” Professor Fabrice Barlesi, MD, PhD, thoracic oncologist, Paris Saclay University and chief executive officer of Gustave Roussy Institute, in France, said in a presentation of the findings. “Overall, these results clearly reinforce adagrasib as an efficacious treatment option for patients including with baseline brain metastasis with previously treated KRAS G12C–mutated NSCLC.”

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.