Published on July 7, 2021
Promising Lung Cancer News from Oncology Conference
Researchers shared encouraging news for people living with non-small cell lung cancer (NSCLC) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which was held online for the second year in a row. From updated clinical trial analyses to novel therapies, lung cancer experts had much to talk about during the conference on June 4-8. Keep reading to learn about ongoing trials, emerging treatments, and recent FDA approvals.
The U.S. Food and Drug Administration (FDA) approved the immune checkpoint inhibitor durvalumab in 2018 for patients with stage 3 unresectable NSCLC whose cancer had not progressed following chemotherapy and radiation. (Unresectable means the tumors cannot be surgically removed.) The FDA based its approval on results from the phase 3 PACIFIC trial, which demonstrated that durvalumab improved progression-free survival (PFS) in this subset of lung cancer patients. (Progression-free survival is defined as the time during and after treatment when a patient lives with the disease but it does not get worse.)
At the ASCO meeting, lead study author David Spigel, MD, chief scientific officer at Sarah Cannon Cancer Institute in Nashville, presented new information about durvalumab based on five-year results from the PACIFIC trial. According to the updated analyses, which are based on results from 709 patients, 42.9% of patients who received durvalumab were still alive five years later, compared to 33.4% of patients who received the placebo. In the durvalumab arm of the trial, 33.1% of patients remained free of disease progression, compared to 19.0% of patients in the placebo arm.
“These updated results based on five-year data from the PACIFIC trial demonstrate robust and sustained overall survival and durable PFS benefits with the PACIFIC regimen,” Dr. Spigel said during a presentation of the data. “This establishes a new benchmark for the standard of care in the unresectable stage III non-small cell lung cancer setting.”
Aumolertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). EGFR is a protein that helps control cell division and survival. It is a type of tyrosine kinase, a group of enzymes that transmit signals telling cells when to divide, among other functions. When EGFR mutates, it causes rapid cell division, helping NSCLC cells to grow and spread quickly. Aumolertinib works by inhibiting, or blocking, the signal that tells the cancer cells to grow. It is showing promise in clinical trials but is not yet approved by the FDA.
At the ASCO meeting, lead study author Shun Lu, MD, PhD, from the Shanghai Chest Hospital at Jiao Tong University in China, shared results from the phase 3 AENEAS trial. According to the study, aumolertinib is more effective than gefitinib (Iressa), an older EGFR TKI, in prolonging PFS in patients with advanced NSCLC with EGFR mutations. Gefitinib is currently a frontline treatment for this subset of patients, but experts continue to look for more effective therapies with fewer and more tolerable side effects.
In the randomized trial, 214 patients received 110 mg of aumolertinib once per day, while 215 patients received 250 mg of gefitinib once per day. Participants in the aumolertinib arm of the study experienced significantly longer PFS than those in the gefitinib arm — a median of 19.3 months compared to 9.9 months. The median duration of response (DOR) was also significantly longer in the aumolertinib group — 18.1 months compared to 8.3 months. (DOR is defined as the length of time a tumor continues to respond to treatment without the cancer growing or spreading).
“Based on these results, we will pursue discussions with global regulatory authorities,” Dr. Lu said during a presentation of the data.
Compared to gefitinib, aumolertinib was also associated with fewer side effects. When side effects did occur, they included liver damage, liver disease, rash, diarrhea, and stress or injury to the muscle tissue, heart, and brain. If the FDA approves aumolertinib, the drug may be an effective alternative to other EGFR TKIs for eligible NSCLC patients.
The FDA approved pralsetinib in 2020 for adult patients with metastatic RET fusion-positive NSCLC. RET stands for “rearranged during transfection.” Patients who are RET fusion-positive have tumors in which a piece of the RET gene fuses to part of another gene. Pralsetinib works by targeting the abnormal protein resulting from this mutation.
The FDA based its approval of pralsetinib on data from ARROW, a clinical trial conducted at 84 sites in 13 countries. At the ASCO meeting, lead study author Giuseppe Curigliano, MD, PhD, an associate professor of medical oncology at the University of Milano in Italy, presented updated results from a larger patient population. The new data set included patients who were treatment-naïve before participating in ARROW, meaning that it was their first line of treatment.
In the updated analysis, 216 NSCLC patients who were RET fusion-positive received 400 mg of pralsetinib once per day and had an objective response rate of 69%. That means that the drug destroyed or significantly reduced tumors in a majority of the patients. The median DOR was 22.3 months, and the median PFS was 16.4 months.
In a subset of 25 patients who enrolled later and received pralsetinib as a first-line therapy, the objective response rate was 88%. (DOR and PFS were not reached in this group.)
“These data solidify the importance of early biomarker testing for all patients with metastatic NSCLC prior to treatment initiation to inform optimal healthcare decisions,” Dr. Curigliano said.
New FDA Approvals for Lung Cancer
In addition to the promising research updates presented at the ASCO meeting, in recent weeks the FDA has approved two new therapies for the treatment of NSCLC.
On May 21, the agency approved amivantamab-vmjw (Rybrevant) as the first FDA-approved targeted treatment for adult patients with advanced NSCLC whose tumors have EGFR exon 20 insertion mutations. This type of mutation is rare, and amivantamab-vmjw is the first FDA-approved targeted treatment option for these patients, who have fewer effective therapies available than patients with the most common EGFR mutations.
On May 28, the agency approved sotorasib (Lumakras) for adult patients with advanced NSCLC who have been treated with at least one prior therapy and have a KRAS G12C mutation. Sotorasib is the first approved targeted therapy for patients with NSCLC and tumors with a KRAS mutation. KRAS is a gene that regulates cell growth. When it mutates, it allows cells to grow uncontrollably. KRAS mutations were considered largely untreatable until recently, but the approval of sotorasib gives patients a promising new option.
To learn more about lung cancer, visit What is Lung Cancer? For questions about any of the therapies listed above, please speak to a lung cancer specialist.
See Our Sources
- Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial. https://meetinglibrary.asco.org/record/196819/abstract
- Randomized phase III trial of aumolertinib (HS-10296, Au) versus gefitinib (G) as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and EGFR exon 19 del or L858R mutations (EGFRm). https://meetinglibrary.asco.org/record/198410/abstract
- Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial. https://meetinglibrary.asco.org/record/200463/abstract
- FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug
- FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-subset-non-small-cell-lung-cancer
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