Key big pharma catalysts to kick off 2022

Oncology, and breast cancer in particular, will be the focus for several big pharma companies in the opening months of 2022. Astrazeneca and Daiichi Sankyo hope to expand Enhertu into Her2-low patients, while Sanofi’s amcenestrant and Gilead’s Trodelvy are both due to yield data in ER-positive, Her2-negative disease. 

Competitors will also be keeping a close eye on Roche’s tiragolumab, the most advanced anti-Tigit antibody, with four pivotal readouts slated for 2022, although the exact timings remain hazy. Outside oncology, late-stage data in respiratory syncytial virus are on the agenda for Glaxo and Pfizer. 

Hitting Her2-low 

Astrazeneca and Daiichi’s Her-2 directed antibody-drug conjugate Enhertu is already on the market for third-line or later Her2-positive breast cancer; the groups are now turning their attention to Her2-low patients, who would not benefit from Herceptin.

The primary endpoint of Destiny-Breast04, Enhertu’s Her2-low trial, is progression-free survival. 

In a phase 1 cohort of 54 Her2-low metastatic patients who were extensively pretreated, Enhertu yielded an ORR of 37%, with a median duration of response of 10.4 months.  

ER-positive, Her2-negative breast cancer will see a couple of pivotal data readouts next year. The Ameera-3 trial of Sanofi’s oral selective oestrogen degrader (Serd) amcenestrant had been expected to report in the second quarter of 2021, but will now yield data early next year. 

Radius and Menarini’s elacestrant has now overtaken amcenestrant to report a hit in its pivotal study, and the Serd space could soon get more crowded, with data expected later in 2022 from Roche and Astrazeneca too (SABCS 2021 – Mutant benefit makes Emerald sparkle, December 7, 2021).  

Serds aside, Gilead’s Trodelvy, an anti-Trop2 drug already on the market in third-line or later triple-negative breast cancer, will also have data soon in ER-positive, Her2-negative disease. 

Results from the upcoming Tropics-02 trial had been expected by the end of 2021, but they are now due early next year, and several amendments – including upsizing and a change in primary endpoint – have dented confidence in the result. Gilead hopes to see a two-month PFS benefit over control. 

Tigit race 

Late-stage data from the most advanced anti-Tigit MAb, Roche’s tiragolumab, are keenly awaited. The company has promised pivotal data in four settings next year but has declined to pin down exact timings. Recruitment has completed into Skyscraper-02, in small-cell lung cancer, so this could read out first; a pivotal phase 2 study in second-line cervical cancer, Skyscraper-04, has also finished enrolling. 

PD-1-high non-small cell lung cancer is the biggest prize. This setting is being tested in Skyscraper-01, with tiragolumab plus Tecentriq. Roche will hope to replicate impressive phase 2 data: in 58 PD-L1 ≥50% patients, the first-line Cityscape NSCLC study showed an ORR of 69% with the combo versus 24% with Tecentriq alone; median PFS was 16.6 months versus 4.1 months.

RSV battleground 

Meanwhile, competition is hotting up in respiratory syncytial virus, with both Pfizer and Glaxo expecting pivotal data with their vaccines early next year. 

Pfizer’s RSVpreF has shown 100% protection in a phase 2 challenge study, and data are expected in the first quarter from the Renoir trial in people aged 60 and older. The same age group is the subject of Glaxo’s Aresvi 004 study testing GSK3844766A, data from which are due in the first half. 

J&J is also in on the vaccine race, but results from its candidate Ad26.RSV.preF are not expected until later in 2022. 

The following table contains a fuller list of catalysts.