Sustain dominance of PARP inhibitor market

Mer­ck and AstraZeneca’s Lyn­parza has been approved by the FDA for first-line main­te­nance ther­a­py of BRCA-mutat­ed ovar­i­an cancer.

“Lyn­parza is now the first PARP inhibitor to be approved as main­te­nance ther­a­py for ovar­i­an can­cer in the first-line set­ting and will most like­ly con­tin­ue to dom­i­nate the PARP inhibitor land­scape. Results from the Phase III SOLO‑1 tri­al pub­lished in Octo­ber 2018 showed that 60% of patients who received Lyn­parza fol­low­ing plat­inum-based chemother­a­py remained pro­gres­sion-free at three years. Con­sid­er­ing that near­ly 70% of women with advanced ovar­i­an can­cer relapse with­in three years of their ini­tial treat­ment, Lyn­parza is posi­tioned to fill a major unmet need for new­ly-diag­nosed patients.

Accord­ing to GlobalData’s report: ‘PARP Inhibitors in Oncol­o­gy’ the total diag­nosed inci­dent cas­es of ovar­i­an can­cer with asso­ci­at­ed germline BRCA1/2 muta­tions are expect­ed to increase over the next 10 years in the eight major mar­kets (8MM), reach­ing 11,267 by 2027.

GlobalData’s pri­ma­ry and sec­ondary research indi­cates that most clin­i­cians view the clin­i­cal effi­ca­cy pro­files of cur­rent­ly mar­ket­ed PARP inhibitors as rough­ly equiv­a­lent. Mer­ck and AstraZeneca have suc­cess­ful­ly cap­i­tal­ized on Lynparza’s first-to-mar­ket sta­tus to build its class lead­ing posi­tion through label and geo­graph­ic expan­sion, win­ning the first approvals for a PARP inhibitor in Chi­na and Japan for treat­ment of plat­inum-sen­si­tive recur­rent ovar­i­an cancer.

On 20 Decem­ber Mer­ck and AstraZeneca also announced pos­i­tive results from the Phase III SOLO‑3 tri­al of Lyn­parza in patients with BRCA-mutat­ed, relapsed ovar­i­an can­cer after two or more lines of chemother­a­py. There remains oppor­tu­ni­ty for the part­ners to con­tin­ue label expan­sions for Lyn­parza in ovar­i­an can­cer, both as main­te­nance and treat­ment monother­a­py as well as com­bi­na­tion therapy.

Although Tesaro’s Zeju­la and Clo­vis Oncology’s Rubra­ca also have approvals in ovar­i­an can­cer, it is unlike­ly that either drug will chal­lenge Lynparza’s posi­tion in this indi­ca­tion. Zeju­la is cur­rent­ly under inves­ti­ga­tion in the Phase III PRIMA tri­al for first-line monother­a­py treat­ment of ovar­i­an can­cer regard­less of BRCA-muta­tion sta­tus, with results expect­ed in late 2019.”

Paul Jeng, Phar­ma Ana­lyst at GlobalData