Approaching datasets for big pharma

Diving into upcoming clinical readouts for big pharma sees J&J awaiting news on its attempt to move its anti-FcRn nipocalimab into rheumatoid arthritis. A win here would open up a potentially big use for this mechanism.

In oncology Bristol Myers Squibb is moving Lag3 into lung cancer with Opdualag, and Astrazeneca’s Akt inhibitor capivasertib will yield data in triple-negative breast cancer. Meanwhile data are still awaited from subcutaneous Keytruda, Enhertu in ultra-low Her2, and datopotamab in lung cancer. 

Move into arthritis 

The anti-FcRn space is crowded with several readouts to watch over the next 12 months. While myasthenia gravis looks to be the lead indication for the space, J&J is expecting proof of concept data in rheumatoid arthritis, a bigger commercial opportunity. 

J&J’s phase 2 study tests intravenous nipocalimab given every two weeks versus placebo, with both arms also on standard of care. The trial is enriched for patients with certain autoantibodies associated with RA, and enrolled those who are TNF-refractory. 

The trial’s primary endpoint is change from baseline in DAS28-CRP, a measure of disease activity, at week 12. Abbvie’s Jak1 inhibitor Rinvoq sets the efficacy bar in rheumatoid arthritis with a delta of around -1.3 between placebo and treatment. However, Rinvoq also comes with a boxed warning so a safety win for nipocalimab would be a bonus. 

Key oncology datasets 

There are several lung and breast cancer readouts coming up for big pharma. In lung cancer, the first Lag3 data from Bristol Myers Squibb are due. The aim is to move Opdualag, a Lag3 and PD-1 combination, beyond its approved use in melanoma. 

An interim look at phase 2 is expected this year. The study is enrolling 420 patients with first-line metastatic NSCLC, and Opdualag plus platinum doublet chemotherapy is pitted against Opdivo plus chemotherapy. The primary measures are adverse events and overall response rate. 

Regeneron’s rival Lag3 asset, fianlimab, in combination with Libtayo, is in two phase 2/3 studies in advanced NSCLC. The trials, one with chemotherapy, and one without, have only recently started recruiting, however. 

In breast cancer, meanwhile, Astrazeneca is set to report data with its Akt inhibitor capivasertib in first-line triple-negative disease. The Capitello-290 study combines capivasertib with paclitaxel versus paclitaxel alone, with overall survival as the primary measure. 

Capivasertib plus Faslodex has already scored in ER-positive Her2-negative breast cancer, where it has a fourth-quarter Pdufa date. Roche has a competing Akt inhibitor, ipatasertib, which has suffered numerous clinical setbacks. 

Worth waiting for 

One oncology catalyst Vantage has dived into before is Merck & Co’s subcutaneous Keytruda formulation, in a lung cancer study called 3475-A86. This could be key to maintaining sales when the intravenous version loses exclusivity in 2028, though recently Merck has been putting the focus on a separate trial, using six-week dosing. 

Investors are also still awaiting data from Daiichi Sankyo/Astrazeneca’s Destiny-Breast06 study, which is intended to move Enhertu into ultra-low Her2 patients. The partners are also due to report key data with another antibody drug conjugate, datopotamab deruxtecan, from Tropion-Lung01 in treatment-refractory NSCLC and Tropion-Breast01 in ER-positive Her2-negative breast cancer.  

There have been hints of efficacy with datopotamab in breast and lung settings, including encouraging response rates in an early first-line lung study, reported at Asco. 

The table below contains a list of upcoming catalysts, with consensus forecasts from Evaluate Pharma. Readouts specifically in the fourth quarter are excluded. 

Evaluate Vantage has published two further catalyst stories, one for big biotech, and the other covering smaller companies.