Baven­cio could use the win.

More than two years af­ter its mak­ers — Ger­many’s Mer­ck KGaA and Pfiz­er — se­cured FDA ap­proval for a form of blad­der can­cer, the com­pa­nies un­veiled that the con­fir­ma­to­ry study test­ing the PD-L1 in­hibitor had per­formed as ex­pect­ed, help­ing pa­tients live longer as a main­te­nance treat­ment ver­sus stan­dard-of-care.

The drug was grant­ed ac­cel­er­at­ed ap­proval on the ba­sis of tu­mor re­sponse and du­ra­tion of re­sponse in May 2017 in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma (UC) whose dis­ease has pro­gressed dur­ing or af­ter plat­inum-con­tain­ing chemother­a­py. On Mon­day, the com­pa­nies said that da­ta from the con­fir­ma­to­ry JAVELIN Blad­der 100 tri­al showed pa­tients treat­ed with Baven­cio lived sig­nif­i­cant­ly longer than those who re­ceived stan­dard care.

A sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival was demon­strat­ed in the Baven­cio arm in each of the co-pri­ma­ry pop­u­la­tions: all ran­dom­ized pa­tients and pa­tients with PD-L1–pos­i­tive tu­mors, the com­pa­ny added, with­out dis­clos­ing the num­bers. The da­ta will be hand­ed over to the FDA.

Baven­cio was late to the check­point in­hibitor game. Mer­ck’s mar­ket-lead­ing Keytru­da and Bris­tol-My­ers’ pi­o­neer­ing Op­di­vo were the first two PD-1/L1 drugs to make the cut, and have since scored var­i­ous ap­provals across im­muno-on­col­o­gy and now reap in bil­lions in sales. Re­gen­eron, Roche and Chi­na-based drug de­vel­op­ers al­so have their own check­points — PARP in­hibitors are al­so the mix.

Last Sep­tem­ber, Cowen an­a­lysts shaved their 2024 pro­jec­tions for Baven­cio by $170 mil­lion to $480 mil­lion, cit­ing flat growth and rel­a­tive­ly few cat­a­lysts ahead. In com­par­i­son, Op­di­vo is ex­pect­ed to gen­er­ate a meaty $12.4 bil­lion that year, and king Keytru­da a hefty $20.6 bil­lion, the an­a­lysts es­ti­mat­ed.

Baven­cio, for which Pfiz­er paid $850 mil­lion up­front in 2014 to part­ner with Mer­ck KGaA on, has had some se­ri­ous set­backs in its quest to make a mark. The part­ners were forced to ad­mit de­feat in ovar­i­an can­cer in March last year af­ter three straight tri­al fail­ures. Months lat­er in No­vem­ber, the drug al­so fiz­zled as a first-line main­te­nance ther­a­py for gas­tric can­cer pa­tients, years af­ter fal­ter­ing in a gas­tric can­cer study to im­prove over­all sur­vival. In 2018, Baven­cio al­so botched a key study in the lu­cra­tive field of lung can­cer.

The com­pa­nies, how­ev­er, did have some luck in kid­ney can­cer. Baven­cio was grant­ed ap­proval in May 2019 in com­bi­na­tion with Pfiz­er’s ty­ro­sine ki­nase in­hibitor In­ly­ta for use as a front­line ther­a­py for re­nal cell car­ci­no­ma, af­ter late-stage da­ta showed the com­bi­na­tion demon­strat­ed a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit. It is al­so ap­proved for use in Merkel cell car­ci­no­ma.

UC ac­counts for about 90% of all blad­der can­cer cas­es. When blad­der can­cer is metasta­t­ic, the five-year sur­vival rate is 5%, ac­cord­ing to Amer­i­can Can­cer So­ci­ety es­ti­mates.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.