Lung Cancer AZ development updates

Durvalumab, neoadjuvant + chemo followed by adj. durva: stage IIA-IIIB resectable NSCLC – P3 AEGEAN (NCT03800134)

• • recently presented data of this trial at AACR 2023 (Abstract #CT005), where the combination demonstrated positive EFS and pCR data versus neoadjuvant chemo alone in this setting
  • these results are set to support approval of this regimen, potentially across stage IIA-IIIB and PD-L1 expression levels. Although this is the first perioperative IO data for resectable NSCLC, the benefit compared to approved neoadjuvant only (nivolumab from P3 CheckMate-816) and adjuvant only (pembrolizumab from P3 KEYNOTE-091 and atezolizumab from P3 Impower010) remains unclear
  • Company anticipates regulatory acceptance in H2 2023

Durvalumab +/- tremelimumab +/- chemo: 1L mNSCLC – P3 POSEIDON (NCT03164616)

• • combination received EU approval in Q1’23 (previously announced Feb’23)

Durvalumab (consolidation therapy): unresectable la/NSCLC not progressed after chemo – P3 PACIFIC-5 (NCT03706690)

• • Company anticipates a data readout in 2024 and subsequent regulatory acceptance in China in >2024 (previously anticipated in H1 2023 according to AZ Q4’22 earnings report)

Dato-DXd (TROP2 ADC): 2L/3L prior CPI and chemo, adv/mNSCLC - P3 TROPION-Lung01 (NCT04656652)

• • Company continues to anticipate a data readout in H1 2023, regulatory filing in H2 2023 (previously H1 2023 according to AZ’s Q4 2022 earnings reports)

Dato-DXd + durvalumab + chemo: 1L la/mNSCLC w/o AGAs – P3 AVANZAR (NCT05687266)

• • Company reiterated this new trial was initiated in 2022 (first posted on clinicaltrials.gov in January 2023)
  • Company anticipates a data readout with a subsequent regulatory acceptance in >2024

Dato-DXd + pembro +/- chemo: 1L/2L+ adv/mNSCLC - P1 TROPION-Lung02 (NCT04526691)

• • Company anticipates a data readout in 2024 (note: updated results are to be presented at ASCO 2023, Abs. 9004)
  • Company guidance is anticipating data readouts in >2024 for the following clinical trials:
  • Dato-DXd + durvalumab +/- chemo: 1L+ adv/mNSCLC – P1b TROPION-Lung04 (NCT04612751)
  • Dato-DXd + pembrolizumab: 1L, PD-L1 ≥50% adv/mNSCLC w/o AGAs – P3 TROPION-Lung08 (NCT05215340)
  • Dato-DXd + pembro +/- chemo: 1L PD-L1 TPS <50% nsq adv/mNSCLC w/o AGAs – P3 TROPION-Lung07 (NCT05555732)

Trastuzumab deruxtecan (T-DXd; HER2 ADC): 2L+ HER2m unresectable, mNSCLC – P2 DESTINY-Lung01 (NCT03505710)

• • Company continues to anticipate EU/JP regulatory decision in H2 2023

Ceralasertib (ATR kinase inhibitor) + Durvalumab: 2L/3L+ adv/mNSCLC w/o AGAs – P3 LATIFY (NCT05450692)

• • Company continues to anticipate a data readout and a subsequent regulatory decision in >2024

AZD2936/ rilvegostomig (anti-TIGIT/anti-PD-1 bispecific mAb): adv./mNSCLC – P1/2 ARTEMIDE-01 (NCT04995523)

• • Company continues to anticipates a data readout in 2024
  • Novel anti-cancer agents (including anti-TIGIT AZD2936/ rilvegostomig): 1L NSCLC – P1 MAGELLAN (NCT03819465)
  • Company disclosed that trial has been discontinued due to strategic portfolio prioritization