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These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.
Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.
“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.
“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
ADRIATIC Methods and Results
The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.
The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.
After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
New Standard of Care for Patients with LS-SCLC
“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.
“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.
Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”
Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.
“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.
“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.
“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”
The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.
Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.
Dr. Campbell has served as an advisor for Novocure and Genentech.
These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.
Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.
“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.
“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
ADRIATIC Methods and Results
The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.
The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.
After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
New Standard of Care for Patients with LS-SCLC
“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.
“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.
Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”
Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.
“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.
“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.
“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”
The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.
Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.
Dr. Campbell has served as an advisor for Novocure and Genentech.
These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.
Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.
“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.
“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
ADRIATIC Methods and Results
The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.
The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.
After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
New Standard of Care for Patients with LS-SCLC
“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.
“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.
Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”
Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.
“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.
“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.
“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”
The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.
Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.
Dr. Campbell has served as an advisor for Novocure and Genentech.
FROM ASCO 2024