Big pharma’s key third-quarter data

Delving into big pharma’s key upcoming data sees GSK trying its luck in rheumatoid arthritis with otilimab, an anti-GM-CSF MAb; this class is littered with setbacks in the autoimmune condition. 

For Roche, convenience could help crovalimab gain market share in paroxysmal nocturnal haemoglobinuria, assuming data are positive. Meanwhile Pfizer will hope to unlock the important infant market with results on its latest pneumococcal vaccine, Prevnar 20. 

Vaccine dominance 

The childhood market makes up around 80% of pneumococcal vaccine sales, and three global studies in infants are expected to report soon on Prevnar 20, Pfizer’s 20-valent conjugate vaccine.  

There is a three-dose regimen, a four-dose regimen and a safety study that also uses four doses. All three global trials use Pfizer’s earlier 13-valent vaccine, Prevnar 13, as control. Separately, an infant study run in Japan that was pegged for data in the first half is yet to report.

Merck & Co is ahead in the infant space with its latest contender, Vaxneuvance. Though this is only a 15-valent conjugate vaccine it received an FDA approval just last week, and has provisional recommendation from the CDC's advisory committee on immunisation practices. 

Others are trying to trump Pfizer’s 20-valent offering. Merck itself has a 21-valent vaccine, V116, which is expected to start phase 3 in adults soon, while GSK and Vaxcyte both have 24-valent contenders in phase 1/2, the former via its recent purchase of Affinivax. For now Pfizer’s dominance looks set to continue, with the sellside expecting the company to have the top-selling vaccine franchise in 2028. 

Right target? 

GSK’s otilimab has already been discontinued in Covid, and next up is its test in rheumatoid arthritis.  

Three phase 3 trials in moderate-to-severe disease are due to yield data: Contrast 1, 2 and 3 ​​​​​​. These 52-week studies will compare 90mg and 150mg of subcutaneous otilimab against placebo, the Jak inhibitor Xeljanz, or the anti-IL-6 MAb Kevzara.  

All are given in combination with methotrexate or other DMARDs. The primary endpoint for all the studies is the proportion of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 versus placebo. 

The earlier phase 2 Baroque study missed its primary endpoint, remission defined as a disease activity score (DAS28(CRP)) of less than 2.6 at week 24. At the time the company called this an “unusual endpoint to be used in phase 2” and blamed underpowering.

However, GSK did claim a benefit on ACR20, and pointed to a placebo-adjusted 40.5% response rate at the highest dose, 180mg – which is not being tested in phase 3.

Still, this result compares favourably against Abbvie’s Rinvoq, which showed a placebo-adjusted ACR20 of 28-37% across three studies.  

The rheumatoid arthritis market is incredibly crowded, and several companies that once pursued anti-GM-CSF MAbs are no longer doing so: Humanigen’s lenzilumab, Roivant’s namilumab and gimsilumab (via its Kinevant business), and Kiniksa’s mavrilimumab all look to have been discontinued.

Aiming for convenience

Meanwhile, Roche hopes to challenge Astrazeneca's dominance of the paroxysmal nocturnal haemoglobinuria market with crovalimab, which is given subcutaneously, rather than intravenously like Astra's Ultomiris and Soliris. 

Data are due from three pivotal crovalimab trials. Commodore-1 is in treatment-experienced PNH patients, testing non-inferiority versus Soliris. The primary measure is mean percentage change in lactate dehydrogenase (LDH) levels, a measure of haemolysis, at weeks 21, 23 and 25. 

Commodore-2 is also a non-inferiority study but in treatment-naïve patients. Here the primary measures are the percentage of participants who achieve transfusion avoidance, and those with haemolysis control at week 25. Lastly, Commodore-3 is a single-arm study in naïve patients in China. All three studies use an intravenous loading dose followed by a subcutaneous maintenance phase. 

The table below contains a list of upcoming catalysts with consensus forecasts from Evaluate Pharma.

Check out our podcast discussing third quarter catalysts here.