1999P - IMreal Cohort 4: Third interim analysis of efficacy and safety in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) receiving atezolizumab plus carboplatin and etoposide (atezo + CE) as first-line (1L) therapy under real-world conditions (RWCs)

Background

Based on the pivotal phase III IMpower133 trial (NCT02763579), atezo + CE is approved for 1L treatment (tx) of ES-SCLC. IMreal (NCT03782207) is a non-interventional, multicentre, multicohort, prospective study of clinical outcomes and safety with atezo under RWCs. We report the third interim analysis efficacy and safety data from Cohort 4 (ES-SCLC).

Methods

Pts with untreated ES-SCLC received 1L atezo + CE. Pt medical and tx history data were retrospectively collected; clinical outcomes and safety data before, during and after atezo + CE tx were also collected. The primary endpoints were OS and 2-y OS. Secondary endpoints included PFS, ORR, DCR and DOR. Safety was assessed.

Results

The full analysis population (N=501) was enrolled from 7 Feb 2019 to 1 Jun 2022. Median follow-up was 6.1 mo (range, 0.0-27.6). The median age was 66 y (range, 34-84), and 293 pts (58%) were ≥65 y; 324 (65%) were male. ECOG PS ≥2 was reported in 33/395 pts (8%). Median OS and PFS were 9.9 mo (95% CI: 8.8, 10.6) and 6.2 mo (95% CI: 5.9, 6.7), respectively; 1-y OS and PFS rates were 39% and 16%, respectively. Additional efficacy data are in the table. In the safety-evaluable population (n=496), 411 pts (83%) had ≥1 AE. The most common any-Gr AEs were anaemia (20% [n=100]), fatigue (17% [n=86]) and neutropenia (17% [n=82]). Gr 3/4 tx-related (TR) AEs occurred in 143 pts (29%); Gr 5 TRAEs occurred in 7 (1%). SAEs occurred in 192 pts (39%) and were TR in 86 (17%). AEs of special interest (AESIs) occurred in 110 pts (22%) and were TR in 74 (15%). The most common any-Gr AESIs were hepatitis (diagnosis and lab abnormalities; 7% [n=34]), rash (6% [n=31]) and hepatitis (lab abnormalities; 6% [n=28]).

Conclusions

In IMreal Cohort 4, OS and PFS differed slightly from those in pivotal ES-SCLC clinical trials, with no new or unexpected safety signals. Table: 1999P

Response-evaluable population (N=390)

DCR, disease control rate; DOR, duration of response; ORR, objective response rate. ^a DCR: proportion of pts who achieved complete response, partial response or stable disease at least 12 weeks after the index date.

Clinical trial identification

NCT03782207.

Editorial acknowledgement

Medical writing support for this abstract, furnished by Michael Williams, PhD, of Health Interactions, Inc., was provided by F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffman-La Roche, Ltd.

Disclosure

S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Merck Serono, Guardant Health, BeiGene, Takeda, Lilly, Roche, Turning Point Therapeutics, GSK, MSD, Pfizer, Sanofi, EQRx; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology; Financial Interests, Personal, Other, Journal Deputy Editor, Lung Cancer: Elsevier; Financial Interests, Institutional, Other, Sub-investigator: Amgen; Financial Interests, Institutional, Coordinating PI: Ariad, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Takeda, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Institutional, Local PI: AstraZeneca, Roche, GSK, Trizel; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Advisory Role, Mesothelioma Task-force Member, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Member of Board of Directors, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Advisory Role, Scientific Adivsory Board Member, Unpaid: Lung Cancer Europe. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer Ingelheim, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Other, Family member is an employee: AstraZeneca. S. Shoshkova: Financial Interests, Personal, Full or part-time Employment: Roche. G. Kok: Financial Interests, Institutional, Other, Cytel (my employer) is contracted as clinical research organization for this and other Roche trials: F. Hoffman La Roche. J.L. Perez Gracia: Financial Interests, Personal, Invited Speaker: Roche, BMS, Ipsen; Financial Interests, Personal, Advisory Board: Seattle Genetics, MSD, Merck; Financial Interests, Institutional, Coordinating PI, Research grant: Roche; Financial Interests, Institutional, Local PI: BMS, Amgen, Astellas; Financial Interests, Institutional, Coordinating PI: Seattle Genetics; Financial Interests, Personal, Funding: Roche.