Key big pharma catalysts to kick off 2022

Important breast cancer data will come in the opening months of 2022, and Glaxo and Pfizer are due pivotal RSV results.

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.

Clinical catalysts in early 2022 (excludes Covid-19 data)
Product Company  Therapy area Clinical catalyst Note/Vantage coverage
Trodelvy Gilead 3L ER+/Her2- breast cancer
(post endocrine therapy & CDK4/6 inhibitor)
Ph3 Tropics-02 due early 2021 See text
Amcenestrant Sanofi 2L ER+/Her2- breast cancer
(post endocrine therapy & CDK4/6 inhibitor)
Ph2 Ameera-3 due early 2021 See text
Milvexian
(BMS-986177)
Bristol Myers Squibb Secondary stroke prevention Ph2 Axiomatic-SSP completes Mar 2022 Eliquis follow-on, positive in ph2 in preventing venous thromboembolism in total knee replacement pts (AHA 2021 – Bristol touts its Eliquis follow-on)
Etrasimod Pfizer (Arena)* Ulcerative colitis Ph3 Elevate UC 52, and Elevate UC 12 due Q1 S1P modulator, previously failed in atopic dermatitis (Pfizer starts to put its vaccine cash to use)
RSVpreF (PF-06928316) Pfizer RSV (in adults ≥60) Ph3 Renoir due Q1 See text
Insulin icodec/
LAI287
Novo Nordisk Type 2 diabetes Ph3 Onwards 2, 3 (insulin naive), 4 due Q1 Once-weekly basal insulin, Lilly's rival project expected to enter ph3 in 2022 (Lilly’s Protomer deal shows innovation in diabetes is not dead)
Efanesoctocog alfa
(BIVV001)
Sanofi/Sobi Haemophilia A Ph3 Xtend-1 due Q1 Extended half-life FVIII, ph1/2a data
suggest BIVV001 is more effective than current long-acting options
Imfinzi Astrazeneca 1L NSCLC Ph3 Pearl (Asia) due H1 Primary endpoint is OS in PD-L1 ≥25% (Tori’s lung cancer hit raises a key question)
Enhertu Astrazeneca 2L Her2-low breast cancer
(1/2 prior lines of chemo/adj)
Ph3 Destiny-Breast04 due H1, primary endpoint PFS See text
GSK3844766A Glaxo-smithkline RSV (in adults ≥60) Ph3 Aresvi 004 due H1 See text
Lebrikizumab Lilly/Roche/ Almirall Atopic dermatitis Ph3 detailed monotherapy data likely at AAD (25-29 March), maintenance data due H1 (Advocate 1, 2) Positive headline data (Lilly leaves investors itching for more details)
Farxiga Astrazeneca Heart failure with  preserved ejection fraction (HFpEF) Ph3 Deliver due H1 Boehringer's Jardiance was filed in Nov on the basis of Emperor-preserved, Pdufa likely Q2 (ESC 2021 – Jardiance blows Entresto out of the water)
Olpasiran
(AMG 890)
Amgen Elevated lipoprotein Ph2 due H1 ApoA RNAi therapeutic, via Arrowhead
Imfinzi
(+ chemo)
Astrazeneca 1L cervical cancer Ph3 Calla due H1 Merck's Keytruda has full approval in 1L PD-L1+ve cervical cancer, and 2L, Sanofi/ Regeneron's Libtayo Pdufa in Jan in 2L (Immuno-oncology spotlight falls on cervical cancer)
Keytruda
(+chemorad)
Merck & Co Locally advanced head and neck cancer Ph3 adj study Keynote-412 due 2022 Keytruda has 1L label (monoRx in PD-L1≥1%, or chemo combo in all-comers), but failed Keynote-040, potentially confirmatory 2L study (Immuno-oncology spotlight falls on cervical cancer)
Keytruda + Lynparza Merck & Co 2L mCRPC Ph3 Keylynk-010 due 2022 To assess combo in patients who have failed androgen receptor targeting and chemo, high bar set by Novartis's 177Lu-PSMA-617 (Pdufa H1; Asco 2021 justifies Novartis’s radioligand Vision)
Tiragolumab
+ Tecentriq
Roche 1L NSCLC PD-L1+, 1L SCLC, 1L oesophageal cancer Ph3 Skyscraper-01 (NSCLC), Skyscraper-02 (SCLC), Skyscraper-08 (esophageal) due 2022 See text
Tecentriq Roche Adjuvant renal cell carcinoma Ph3 Immotion-010 due 2022 Primary endpoint DFS (Keytruda’s latest kidney cancer win: adjuvant use)
ABBV-3067 +/- ABBV-2222
Also triplet:
+ ABBV-119
Abbvie Cystic fibrosis Ph2 potentiator + corrector
Ph2 two correctors + potentiator due 2022
Via Galapagos (Abbvie’s low-risk bet could challenge Vertex on price)
*Pfizer bought Arena on 13 Dec. Source: clinicaltrials.gov, Evaluate Pharma & company releases.

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