Roche’s Kadcyla needs some oomph, and the Swiss drugmaker’s new data might just do the trick. The company is teeing up a new filing for its next-generation breast cancer drug, hoping to gin up more sales as its ancestor, Herceptin, moves ever closer to biosimilar competition in the U.S.
The news comes as Roche rolls out top-line data from its phase 3 Katherine study, which focused on treating patients after surgery. The med targets HER2-positive breast cancer, and as an armed antibody is designed to zero in on tumors to deliver a one-two punch of Herceptin’s active ingredient and DM1 chemotherapy.
In the study, post-surgery Kadcyla beat Herceptin at fending off disease recurrence or death—called invasive disease survival—in patients who’d received treatment before surgery but didn’t fully respond.
Details of the study are set for a rollout Dec. 5 at the San Antonio Breast Cancer Symposium, and Roche is taking the data to the FDA and European regulators in the meantime.
Kadcyla could use the boost. It’s never quite performed up to expectations, despite the anticipation before its approval. At its FDA nod in 2013, analysts projected peak sales of up to $5 billion. Last year, the drug brought in 914 million Swiss francs, or about $927 million. Herceptin’s strong hold on the HER2-positive breast cancer market left Kadcyla toiling to grab market share, despite its first-of-its-kind technology. And Kadcyla itself has fallen short in at least one major trial against Herceptin, plus failed a gastric cancer trial that could have expanded the med into a new field altogether.
Roche’s other next-generation breast cancer launch, Perjeta—envisioned partly as a companion drug for Herceptin, and eventually Kadcyla—has eclipsed the latter’s sales. That’s partly thanks to preadjuvant, or pre-surgery, and post-surgery approvals in tandem with Herceptin. Perjeta delivered 2.2 billion Swiss francs for Roche last year, or about $2.23 billion at today’s exchange rates.
If Kadcyla can snare a new approval, that will give it more ammunition to capture patients who might otherwise use Herceptin. And with Herceptin hurtling toward biosimilar competition in the U.S., Roche needs to build up Kadcyla as much as it can. Even with biosims taking share in other countries, Herceptin remains Roche’s top seller at more than 7 billion Swiss francs worldwide last year.
Mylan and Biocon settled with Roche for a mid-2019 launch of their FDA-approved knockoff, giving the partners a first chance at nabbing Herceptin share, Bernstein analyst Ronny Gal wrote in an investor note.
But Roche isn’t taking Herceptin biosimilars lying down. Last year, it sued Pfizer over its candidate, which got turned back by the FDA in April. And just last month, Roche went after another biosim marker, Samsung Bioepis, citing 21 different patents; their biosim is aiming for a December approval.