The Targeted Pulse: ODAC Deems MRD for End Point in MM, A Deep Dive Into Amivantamab in NSCLC, and More

ODAC Validates MRD as an Accelerated Approval End Point in Myeloma Trials

In the FDA’s recent Oncologic Drugs Advisory Committee (ODAC) meeting, participants voted that minimal residual disease (MRD) can serve as an accelerated approval end point in clinical trials for multiple myeloma.

“I think this sets a precedence of moving the field forward, not only for the patients to get the drug earlier, but can we stop therapy based on MRD? If the duration of MRD is longer with better treatments, it opens up a whole other way of maybe treating patients where you don’t have this continuously, [and] where you can get treatment gaps like you do in solid tumors,” said ODAC member Ranjana H. Advani, MD, the Saul Rosenberg Professor of Lymphoma, Division of Oncology, Stanford University School of Medicine.

Improving Analysis of Ovarian Cancer Trends in Asian American Subgroups

Researchers set out to analyze trends in ovarian cancer diagnosis for Asian American patient subgroups in order to improve identification in a growing demographic. Patients were segregated by their specific ethnicity or country of origin through electronic health records data and their main spoken language.

“Asian Americans are sometimes [grouped] under the category of “other,” but oftentimes, Asian American and Pacific Islander patients are grouped as “AAPI” in studies. Despite the fact that there [are] 20 million [Asian Americans] and [it is the] fastest growing racial ethnic subgroup in the US, we thought that we should better understand how these patients are divided or disaggregated,” Sarah Lee, MD, MBA, explained. Lee is a gynecologic oncology fellow at NYU Langone.

Exploring Pros and Cons of Amivantamab in NSCLC Subgroups

The phase 1b CHRYSALIS study (NCT02609776) investigated the efficacy and safety of amivantamab (Rybrevant) in patients with wild-type non-small cell lung cancer, including adenocarcinoma and squamous cell carcinoma, who progressed after standard therapy with platinum-based chemotherapy and anti-PD(L)1 agents.

“What was very interesting to us was the activity…using plasma [circulating tumor DNA] or liquid biopsies, we were able to look at patients based on genotyping. We found that if patients had KRAS or HER2 alterations in their tumor, they were unlikely to have a response or benefit…We also saw very similar and unexpected findings in patients with wild-type squamous lung cancer,” Natasha Leighl, MD, MMSc, BSc explained. Leighl is lead of medical oncology at Princess Margaret Cancer Centre in Toronto, Ontario, Canada, and professor of medicine at the University of Toronto.

LYT-200 Gains Fast Track Designation in Head and Neck Cancers

LYT-200 has been given a fast track designation by the FDA for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), and is an antibody directed against galectin-9. A phase 1/2 trial (NCT04666688) is evaluating the agent alone and in combination with chemotherapy or tislelizumab (Tevimbra) in patients with locally advanced or metastatic solid tumors, including HNSCC.

“As galectin-9’s role in suppressing immune-mediated activity has been well-validated, it represents an important area of clinical research, especially in aggressive cancers with increased mortality.” Aleksandra Filipovic, MD, PhD said. Filipovic is head of oncology at PureTech Health.

Rivoceranib Misses the Primary End Point of OS in Gastric/GEJ Cancer

Rivoceranib (apatinib) did not improve overall survival (OS) when compared with placebo in patients with gastric or gastroesophageal junction cancer. This was the primary end point of the phase 3 ANGEL trial (NCT03042611) evaluating the agent; however, trial data showed benefits progression-free survival rates.

“While improvement of OS remains the gold standard for oncology studies and the ultimate goal for new therapies, it remains an end point that can be easily confounded or diluted, principally by poststudy anticancer therapies…The OS benefit observed in patients receiving rivoceranib in the 4th or greater line warrants further study in a dedicated trial of this subgroup,” study authors wrote.

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