Summary
UNPRECEDENTED OS and PFS results with IMFINZI® following CRT in LS-SCLC2
Efficacy
Over 22 months improvement in median OS2
- Median OS: 55.9 months with IMFINZI® following CRT vs 33.4 months with placebo
(HR=0.73, 95% CI, 0.57-0.93; P=0.0104)
Significant PFS benefit: 7 months longer median PFS2
- Median PFS: 16.6 months with IMFINZI® following CRT vs 9.2 months with placebo
(HR=0.76, 95% CI, 0.16-0.95; P=0.0161)
Consistent OS and PFS improvement independent of prior PCI use and CRT components2
Safety
Manageable safety profile consistent with the known safety profiles of IMFINZI® in the post-CRT setting (PACIFIC study)2,3
* To date, status: 11/2024.
CI: confidence interval; CRT: chemoradiation therapy; HR: hazard ratio; LS-SCLC: limited-stage small cell lung cancer; OS: overall survival; PCI: prophylactic cranial irradiation; PD-L1: programmed death ligand 1; PFS: progression-free survival.
Study design
IMFINZI® is the first systemic treatment advancement in decades to show improved survival outcomes in the treatment of LS-SCLC2
ADRIATIC was a global, Phase III, double-blind placebo-controlled, randomized trial that evaluted IMFINZI® following cCRT in LS-SCLC2
ADRIATIC: Study design2
* cCRT and PCI treatment, if received per local standard of care, must have been completed within 1-42 days prior to randomization.
† If disease control was achieved and no additional benefit was expected with an additional cycle of chemotherapy, in the opinion of the investigator.
‡ The first 600 patients were randomized in a 1:1:1 ratio to the 3 treatment arms; subsequent patients were randomized 1:1 to either IMFINZI® or placebo.
BICR: blinded independent central review; BID: twice daily; cCRT: concurrent chemoradiation therapy; CT: chemotherapy; LS-SCLC: limited-stage small cell lung cancer; OS: overall survival; PCI: prophylactic cranial irradiation; PFS: progression-free survival; PS: performance status; Q4W: every 4 weeks; QD: once daily; R: randomization; RECIST: Response Evaluation Criteria in Solid Tumors; RT: radiotherapy; WHO: World Health Organization.
Results
- OS benefit
- OS in subgroups
- PFS benefit
- PFS in subgroups
UNPRECEDENTED overall survival results demonstrated with IMFINZI® following CRT vs placebo2
OVERALL SURVIVAL
Adapted according to Cheng Y et al., 2024.2
MEDIAN OS
months
with the
ADRIATIC regimen
months
with placebo
IMFINZI® in LS-SCLC is the first systemic treatment advancement in decades2
CI: confidence interval; CRT: chemoradiation therapy; HR: hazard ratio; LS-SCLC: limited-stage small cell lung cancer; OS: overall survival.
Safety
- Safety summary2,#
- Profile of adverse events2
Adapted according to Cheng Y et al., 2024.2
# Includes AEs with an onset date following first dose of study treatment, or pre-treatment AEs that increased in severity following first dose of study treatment, through to 90 days after last dose or until start of the first subsequent systemic anticancer therapy (whichever occurred first).
* Assessed by investigator.
† Defined as an AE of special interest (excluding infusion related/hypersensitivity/ anaphylactic reaction) that is consistent with an immune-mediated mechanism that required treatment with systemic corticosteroids, other immunosuppressants, or endocrine therapy.
‡ Causes of death were encephalopathy and pneumonitis.
AE: adverse event.
Treatment and dosing
Initiate IMFINZI® as soon as clinically appropriate after the completion of CRT2
THE ADRIATIC REGIMEN
- Patients benefit most if treatment is initiated within 14 days after CRT2
- Following cCRT, 33.5% of patients completed the full 2 years of IMFINZI®2
IMFINZI® offers Q4W fixed dosing1,#
IMFINZI® is administered as a 60-minute IV infusion with no premedication required
IMFINZI® fixed 1500-mg dose
Q4W
until disease progression, unacceptable
toxicity, or up to 24 months#
* Patients must have achieved CR, PR, or SD, and have not progressed following CRT. PCI treatment is permitted.
† Infuse IMFINZI® for up to 24 months or until disease progression or unacceptable toxicity.
# Patients with a body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI® 10 mg/kg every 2 weeks. Refer to Prescribing Information for information on dosage modifications.
cCRT: concurrent chemoradiation therapy; CR: complete response; CRT: chemoradiation therapy; CT: chemotherapy; IV: intravenous; PCI: prophylactic cranial irradiation; PR: partial response; Q4W: every 4 weeks; RT: radiation therapy; SD: stable disease.
References
- IMFINZI® Information for Healthcare Professionals. www.swissmedicinfo.ch.
- Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327.
- Antonia SJ, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929.
Professionals can request the mentioned references from AstraZeneca AG.