35MO - Quality-adjusted survival in patients with advanced or recurrent endometrial carcinoma treated with atezolizumab in combination with carboplatin-paclitaxel versus carboplatin-paclitaxel in the AtTEnd/ENGOT-EN7 trial

Background

In the phase III randomized international multicentric academic AtTEnd trial, the addition of atezolizumab (atezo) to standard carboplatin and paclitaxel chemotherapy (CP) demonstrated a statistically significant improvement in progression free survival versus CP alone for patients (pts) with advanced/recurrent endometrial carcinomas (EC) with a substantial benefit in pts with a mismatch repair deficient (dMMR) carcinoma. This is a post-hoc analysis of the quality-adjusted time without symptoms of disease progression or toxicity of treatment (Q-TWiST) in dMMR and all comer population.

Methods

Pts were randomized (2:1 ratio) to receive either CP and atezo (N=360) or placebo (N=189), followed by atezo or placebo until disease progression. In safety population (356 pts in atezo arm and 185 pts in placebo arm), overall survival was partitioned into three health status: the time without symptoms of progression or toxicity (TWiST), the time before progression with Grade ≥ 3 adverse events (TOX), and the time from progression to death (REL). The restricted mean survival time (measured up to 36 months for the all-comers population and 23 months for the dMMR population) of each health status were adjusted using EQ-5D-5L questionnaire. Q-TWiST was calculated using the utility values for TOX and REL defined relative to TWiST.

Results

Overall, median follow-up duration was 28.3 months. In pts receiving atezo a significantly longer Q-TWiST was detected compared to pts receiving placebo (25.9 versus 24.0 months, p=0.0144). Q-TWiST was also significantly longer in atezo arm compared to placebo arm (20.3 versus 16.2 months, p<0.0001) for patients with a dMMR carcinoma (Table). Table: 35MO

Conclusions

In pts with advanced/recurrent EC, the addition of atezo to CP improved the quality-adjusted survival compared to CP alone.

Clinical trial identification

EudraCT 2018-001072-37; NCT03603184.

Legal entity responsible for the study

Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, Milan.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

M.P. Barretina Ginesta: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, MSD, Eisai, PharmaMar; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, MSD, Eisai, MSD. K. Harano: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Takeda; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Chugai, Takeda; Financial Interests, Institutional, Research Grant: Merck, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: MSD, Daiichi Sankyo, Takeda; Non-Financial Interests, Personal, Principal Investigator: Merck, Chugai. E. Hudson: Financial Interests, Personal, Advisory Board: GSK, Clovis, Roche. Y. Antill: Non-Financial Interests, Personal, Advisory Board, compensated role: AstraZeneca, Eisai, MSD, GSK. I. Braicu: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal and Institutional, Advisory Board, Insitution, AdBoard: MSD; Financial Interests, Personal and Institutional, Other, Institution, travel, AdBoard, Talks: AstraZeneca; Financial Interests, Institutional, Research Grant: Roche Diagnostic, Incyte, Roche, Bayer, Clovis, Resolve; Non-Financial Interests, Personal, Other, Medical Director NOGGO: North Eastern German Society of Gynecological Oncology (NOGGO). A. Redondo: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, GSK, PharmaMar, Pharma&; Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, GSK, PharmaMar, Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Roche, Eisai, PharmaMar. K. Takehara: Financial Interests, Personal, Speaker’s Bureau: Takeda, AstraZeneca, Chugai Pharma, MSD, Eisai, Mochida Pharma, Nippon Kayaku, Zeria Pharma, Sanofi, Kracie Pharma, Ethicon/ Johnson & Johnson, Terumo, Tsumura & co. Y.C. Lee: Financial Interests, Institutional, Funding: BeiGene. I. Palaia: Financial Interests, Personal, Other, Consulting: GSK, AstraZeneca. N. Colombo: Financial Interests, Personal, Advisory Board, Various: Roche, AstraZeneca, MSD/Merck, Clovis Oncology, GSK, Immunogen, Mersana; Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: AstraZeneca; Financial Interests, Personal, Advisory Board, Lectures: Eisai; Financial Interests, Personal, Advisory Board, Advisory role: Nuvation Bio, Pieris; Financial Interests, Personal, Advisory Board, Advisory Role: Onxerna; Financial Interests, Personal, Invited Speaker: MSD/Merck; Financial Interests, Personal, Invited Speaker, Speaker: GSK; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, GSK; Non-Financial Interests, Personal, Other, Steering Committee, member Clinical Guidelines: ESMO; Non-Financial Interests, Personal, Leadership Role, Chair, Scientific Committee: ACTO (Alleanza contro il tumore ovarico). All other authors have declared no conflicts of interest.