New Hope for a Subset of Lung Cancer Patients
- A drug called osimertinib (brand name: Tagrisso) has shown real promise in treating EGFR-mutated stage 3 lung cancer, according to research presented at this year’s American Society of Clinical Oncology (ASCO) conference.
- The EGFR (epidermal growth factor receptor) is a protein in cells that helps them grow. If there’s a mistake in the gene for EGFR, it can make it grow too much, leading to cancer. It’s important to test patients for this mutation.
- Tagrisso has previously shown promise in treating other types of EGFR-mutated cancer — but the new research indicates it can also treat stage 3 cancer that is non-operable.
- Dr. Suresh Ramalingam, executive director of Winship Cancer Institute of Emory University and the principal investigator of the study, told SurvivorNet that the results will likely change the standard of care for patients with stage 3 EGFR-mutated lung cancer that cannot be removed with surgery.
A drug called osimertinib (brand name: Tagrisso) is showing even more promise in treating a specific type of lung cancer known as EGFR-mutated lung cancer. The latest trial results for the drug were presented at this year's American Society of Clinical Oncology (ASCO) conference, a major cancer conference held each spring where the latest in cancer research is shared.
AstraZeneca’s drug Tagrisso (osimertinib) is now showing exciting results for stage 3 lung cancer patients. Tagrisso is the first and only EGFR inhibitor and targeted treatment to show benefit in EGFR-mutated unresectable (which means it can't be surgically removed) stage 3 non-small cell lung cancer (NSCLC). The EGFR (epidermal growth factor receptor) is a protein in cells that helps them grow. If there’s a mistake in the gene for EGFR, it can make it grow too much, leading to cancer. Because Tagrisso targets EGFR, it is showing real promise in treating the specific subset of patients whose lung cancer is EGFR-mutated.
What to Know About EGFR-Mutated Cancer
Updated results from the
phase III LAURA study that could change the current standard of care were presented at the 2024 ASCO conference. “The LAURA study shows clinically and statistically significant improvement in progression-free survival for patients treated with osimertinib. The median PFS [progression-free survival] increased from 5.6 months in the control group to 39.1 months with osimertinib, thus causing an 84% reduction in the risk of progression,"
Dr. Suresh Ramalingam , executive director of Winship Cancer Institute of Emory University and the principal investigator of the study, told SurvivorNet. "To me, these are clinically highly meaningful results and will change the standard of care for stage 3 unresectable patients with an EGFR mutation," Dr. Ramalingam added. The Food and Drug Administration (FDA) has already approved Tagrisso in patients with early-stage EGFR-mutated NSCLC who underwent curative surgery followed by chemotherapy. In addition, it is also approved in EGFR-mutated advanced or metastatic lung cancer.
Tagrisso has already been approved for early-stage and advanced EGFR-mutated lung cancer. What's the Significance of the New Research?
The majority of
stage 3 non-small cell lung cancers are surgically inoperable. At this time, the current standard of care in this setting is typically a combination of chemotherapy and radiation therapy followed by one year of immunotherapy. Currently, there are no targeted therapies available for patients with EGFR-mutated, unresectable, stage 3 lung cancer. Thus, these findings are a game changer to improve outcomes for these patients. “Immunotherapy does not benefit patients with EGFR-mutated lung cancers. We've seen this in multiple studies, so we specifically wanted to see if EGFR inhibition, which is osimertinib in this case, will benefit patients with stage 3 disease," Dr. Ramalingam explained. This study highlights the importance of making sure those with lung cancer are tested for the EGFR mutation to determine if Tagrisso is an appropriate treatment option for them. Oncologists treating stage 3 lung cancer should strongly consider Tagrisso given its proven capacity to significantly enhance progression-free survival.
What is Tagrisso (osimertinib)?
Certain lung cancers have genetic mutations that help them grow and spread, such as EGFR mutation.
EGFR mutations in lung cancer help the cancer cells to proliferate. When these mutations exist, targeted drugs can block those mutations to stop abnormal cancer cell growth. Tagrisso belongs to a class of drugs called
tyrosine kinase inhibitors (TKIs) . It binds to the mutated EGFR protein on the surface of cancer cells. This prevents the protein from being activated and this ultimately blocks cancer growth and survival. If lung cancer has a mutation in EGFR, it is called an EGFR-mutated lung cancer. EGFR mutations can be present in up to one-third of patients with unresectable stage 3 NSCLC. Knowing this information can affect the treatment decisions and therapy plan. “Until now, there was no compelling reason to test patients with stage 3 for EGFR mutation because there wasn't a specific targeted therapy," Dr. Ramalingam explained to SurvivorNet. "Now the first step of making sure patients have access to this treatment is to see if they have the mutation. So, I would first make the case that we need to educate our healthcare community and the teams that stage 3 patients should have their tumor tested for EGFR mutation. Number two, if they do have an EG FFR exon 19 or 21 mutation, they should all be considered for osimertinib therapy." It's important to note that there are different types of EGFR mutations — and some may respond better to available targeted therapies than others. EGFR testing can be performed on the tissue obtained from the biopsy or using a blood sample. The test results can determine additional information about the makeup of cancer, which is used to make treatment decisions.
The Study's Results
The LAURA trial was a phase 3, double-blind, placebo-controlled trial involving a total of 216 patients with unresectable EGFR-mutated stage 3 NSCLC without progression during or after chemotherapy and radiation. “Patients with stage 3A, 3B and 3C were enrolled," Dr. Ramalingam explained. "They were deemed by their treating physician and treating teams to have surgically unresectable disease and they were required to have either an EGFR exon 19 or 21 mutation. "They had all completed chemotherapy and radiation, and they entered this study within six weeks of having completed chemotherapy and radiation and they did not have disease progression.” Treatment with Tagrisso was shown to improve progression-free survival — or the amount of time that a patients lives without their disease getting any worse.
- Median progression-free survival was 39.1 months with Tagrisso versus 5.6 months with placebo
- Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib and 74% with placebo
- The percentage of patients who were alive and progression-free at 12 months was 74% with osimertinib and 22% with placebo
- The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group
- No new safety concerns emerged
“By giving osimertinib, we were able to reduce the likelihood of progression in the brain. We were able to reduce the likelihood of progression within the lung or the lymph nodes and any progression for that matter," Dr. Ramalingam explained. "And while the survival results are not fully mature, we hope to see those data in the next 18 to 24 months. We see a promising trend in favor of patients who received osimertinib. So, all of this add to osimertinib being a highly effective intervention for patients that provides hope for a longer life and a better life. “Barring that there were no undue safety concerns, so the treatment was tolerated well, and you have a substantial improvement in outcome and that's why we're excited and we think this is going to change the standard of care for patients with stage 3 unresectable non-small cell lung cancer, bearing an EGFR mutation," he added.
What are the Side Effects?
The side effects were relatively mild, and none of the participants discontinued treatment due to side effects. Safety results for Tagrisso are consistent with prior results, and no new safety concerns were observed. “When patients complete chemotherapy and radiation, the most common side effect we see for the next few months is radiation pneumonitis [inflammation of the lungs caused by radiation therapy]. Steroids are often used to suppress that," Dr. Ramalingam explained. He noted that the most common observed side effects were:
- Radiation pneumonitis
- Skin rash
- Diarrhea
"Thankfully these are very mild. In the majority of the patients, we rarely see serious levels of this toxicity," Dr. Ramalingam explained. "These can be managed with the appropriate topical interventions, and anti-motility drugs that are used to control the diarrhea. And in my practice, these toxicities seldom lead to the patients having to stop therapy." These trial results are monumental, especially since historical and current treatments for EGFR-mutated unresectable stage 3 lung cancer patients have been lacking.
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