As­traZeneca, Mer­ck score a block­buster ad­vance as Lyn­parza comes through in front­line ovar­i­an can­cer

As­traZeneca’s on­col­o­gy R&D team has suc­cess­ful­ly hit an­oth­er land­mark mile­stone.

The phar­ma gi­ant along with its part­ners at Mer­ck are drum­ming up new, block­buster-sized mar­ket ex­pec­ta­tions for its PARP in­hibitor Lyn­parza as a first-line main­te­nance treat­ment in ovar­i­an can­cer with a quick, top-lev­el an­nounce­ment of their late-stage suc­cess to­day.

Sean Bo­hen

In a Phase III tri­al dubbed SO­LO-1, Lyn­parza “sig­nif­i­cant­ly” de­layed dis­ease pro­gres­sion in women with BR­CA-mu­tat­ed ad­vanced ovar­i­an can­cer — the pri­ma­ry end­point. There’s no word on the da­ta just yet, which will be care­ful­ly stud­ied as an­a­lysts as­sess mar­ket im­pact. In­ves­ti­ga­tors gen­er­al­ly hold on to the de­tails for an up­com­ing con­fer­ence — in this case quite pos­si­bly ES­MO in Oc­to­ber.

“For the first time, we see a sig­nif­i­cant and clin­i­cal­ly-im­pact­ful im­prove­ment in pro­gres­sion-free sur­vival in the 1st-line main­te­nance set­ting for women with BR­CA-mu­tat­ed ovar­i­an can­cer treat­ed with a PARP in­hibitor,” said As­traZeneca CMO Sean Co­hen. “The SO­LO-1 da­ta re­in­force the im­por­tance of know­ing BR­CA sta­tus at di­ag­no­sis, as this may en­able women with BR­CA-mu­tat­ed ovar­i­an can­cer to re­ceive Lyn­parza ear­li­er.”

Lyn­parza was the first of three PARP in­hibitors to make it to the mar­ket, set­ting the stage for a big al­liance with Mer­ck and stay­ing well ahead of a small pack of ri­vals from Clo­vis and Tesaro. Pfiz­er will soon join that crowd, with­out dis­tin­guish­ing its PARP so far. Now As­traZeneca and Mer­ck plan to push hard for reg­u­la­to­ry ap­proval to go af­ter the added mar­ket here, which some an­a­lysts be­lieve will like­ly add $1 bil­lion-plus in new rev­enue.

That’s par­tic­u­lar­ly cru­cial for As­traZeneca, which has been mak­ing sig­nif­i­cant ad­vances in on­col­o­gy, in­clud­ing re­cent suc­cess­es for its PD-L1 in­hibitor Imfinzi. These suc­cess­es are key to CEO Pas­cal So­ri­ot’s promise of a turn­around at As­traZeneca, and won’t go un­no­ticed.

Fail­ure was not an op­tion, ac­cord­ing to Leerink, which sev­er­al months ago not­ed:

AZN/MRK’s SO­LO1 (Lyn­parza) study in the 1L main­te­nance set­ting for BR­CA-mu­tat­ed ovar­i­an can­cer ex­pect­ed in 1H18 is a high ex­pec­ta­tions “must suc­ceed” cat­a­lyst to val­i­date the as­sumed ex­pan­sion to 1L main­te­nance for the PARP class.

More da­ta are to come, ac­cord­ing to As­traZeneca and Mer­ck, which paid $1.6 bil­lion up­front last year to co-de­vel­op and co-com­mer­cial­ize the drug. They added that a sep­a­rate Phase III study test­ing a com­bo of Lyn­parza and Avastin in women with new­ly-di­ag­nosed ad­vanced ovar­i­an can­cer re­gard­less of their BR­CA sta­tus is ex­pect­ed to pro­duce re­sults in 2019. That would po­ten­tial­ly set up a case for Lyn­parza to be a first-line main­te­nance ther­a­py af­ter chemo, which is the stan­dard com­pan­ion with Avastin in this set­ting.


With con­tri­bu­tion by John Car­roll.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Paul Hudson, Sanofi CEO (Getty Images)

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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