In a “check the box” ex­er­cise, Roche said it has shown that adding Tecen­triq to a com­bo of Cotel­lic and Zelb­o­raf was ef­fec­tive in ex­tend­ing pro­gres­sion-free sur­vival in melanoma pa­tients com­pared to place­bo plus the two drugs.

Pa­tients with pre­vi­ous­ly un­treat­ed BRAF V600 mu­ta­tions were re­cruit­ed to the Phase III study, dubbed IM­spire150.

Levi Gar­raway

Cotel­lic (which was ini­tial­ly de­vel­oped by Roche part­ner Ex­elix­is) and Zelb­o­raf are al­ready ap­proved to treat BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. While the lat­ter blocks some BRAF ki­nas­es, the for­mer is be­lieved to help break treat­ment re­sis­tance by al­so in­hibit­ing MEK1/2.

Some­times, though, that’s still not enough, thus the at­tempts to add a third agent to in­crease the dura­bil­i­ty of treat­ment — ei­ther a tar­get­ed ther­a­py or, in this case, an im­munother­a­py.

Roche has tried to test a com­bo of Tecen­triq plus just Cotel­lic for treat­ment-naive cas­es, but that com­bi­na­tion failed to beat stan­dard-of-care Keytru­da in a sep­a­rate tri­al, IM­spire170, un­veiled ear­li­er this year.

The phar­ma gi­ant record­ed around $44 mil­lion in Cotel­lic sales in the first three quar­ters of 2019, while Tecen­triq fetched over $1.3 bil­lion.

Cotel­lic and Zelb­o­raf had two heavy­weight ri­vals in No­var­tis, which mar­kets Mekin­ist and Tafin­lar, as well as Pfiz­er af­ter it snapped up Ar­ray and its Mek­tovi/Braftovi pair­ing. All play­ers are look­ing to go be­yond melanoma now — Pfiz­er is es­pe­cial­ly keen about the prospects in col­orec­tal can­cer — though Roche has suf­fered some set­backs.

Stifel an­a­lyst Stephen Wil­ley has pre­vi­ous­ly de­scribed the triplet vs dou­blet com­par­i­son as more of a “check the box” than “ex­pand the mar­ket” move.

The next step will be to check the reg­u­la­to­ry box.

“By com­bin­ing a can­cer im­munother­a­py with tar­get­ed ther­a­pies, we hope to of­fer a new ap­proach that im­proves out­comes for peo­ple with ad­vanced, BRAF-mu­tant melanoma,” CMO Levi Gar­raway said in a state­ment.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.