Esmo 2022 preview – front-line liver cancer showdown

As Esmo yesterday briefly published the titles of late-breaking abstracts (most were gone this morning), investors have their first clues about what to expect at the oncology conference, which starts in Paris on September 9. One of the highlights will be a trio of pivotal studies of anti-PD-1 MAbs in first-line hepatocellular cancer: Keytruda’s Leap-002, known to have failed, camrelizumab’s SHR-1210-III-310, toplined positive, and tislelizumab’s Rationale-301, said to show non-inferiority versus Nexavar. Biotech watchers have key presentations on Relay’s RLY-4008 – look out for toxicities – Biontech’s BNT211 and Springworks’ nirogacestat, not to mention Padcev’s EV-103 cohort K, seen by some as smoothing the way to Seagen’s takeover by Merck & Co. Also closely watched will be colorectal cancer data from Mirati’s adagrasib, though a path for filing here has yet to be outlined, and of more immediate importance is the accelerated application for NSCLC, given upcoming release of confirmatory data on Amgen’s competitor, Lumakras. Major failed studies being highlighted include Roche’s Immotion-010 and Sanofi’s Ameera-3; The French group recently discontinued amcenestrant on the basis of Ameera-3 and 5. With Gilead’s Tropics-02 set to be one of the most picked-apart datasets Esmo is shaping up to be full of catalysts.

Selected Esmo 2022 abstracts
Project (company) Study (use) Note Abstract
Keytruda + Lenvima (Merck & Co/Eisai) Leap-002 (1L liver) Known to have failed OS & PFS vs Lenvima alone LBA34
Camrelizumab + rivoceranib (Jiangsu Hengrui) SHR-1210-III-310 (1L liver) Known to have succeeded vs Nexavar; approved in China for 2L liver LBA35
Tislelizumab (Beigene/ Novartis) Rationale-301 (1L liver) Known to have succeeded on non-inferiority vs Nexavar LBA36
Dalpiciclib/ SHR 6390 (Jiangsu Hengrui) SHR6390-III-302 (1L HR+/Her2- breast cancer) CDK4/6 inhibitor LBA16
Oleclumab (Astrazeneca) Synergy (TNBC) Anti-CD73 combos LBA17
Trodelvy (Gilead) Tropics-02 (2L HR+/Her2- breast cancer) Modest PFS benefit, recently met 2nd interim OS analysis 214MO
Amcenestrant (Sanofi) Ameera-3 (2L HR+/Her2- breast cancer) Failed study, Serd recently discontinued by Sanofi 212MO
Nirogacestat (Springworks [ex Pfizer]) DeFi (desmoid tumours) Known to have succeeded LBA2
RLY-4008 (Relay) ReFocus (FGFR inhibitor-naive cholangio) Tox problems at Triple meeting 2021 LBA12
Adagrasib (Mirati) Krystal-1 (Kras G12C+ve colorectal cancer) Colorectal filing path unclear LBA24
BNT211 (Biontech) BNT211-01 (mRNA vaccine combo) Anti-Claudin-6 Car-T, early data at AACR 2022 LBA38
Naporafenib/ LXH254 (Novartis) Unclear (melanoma) Various combos LBA40
MEDI5752 (Astrazeneca) D7980C00001 (1L NSCLC chemo combo) PD-1xCTLA-4 bispecific vs vs Keytruda LBA56
Tecentriq (Roche) Immotion-010 (adjuvant renal) Known to have failed LBA66
Padcev + Keytruda (Seagen/ Merck & Co) EV-103 cohort K (1L bladder) Known to have succeeded; possible route to AA LBA73
Source: Esmo website, company statements &

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