Treatment of Patients with advanced renal cell carcinoma

Mer­ck and Pfiz­er announced that the Euro­pean Com­mis­sion (EC) has approved Baven­cio (avelum­ab) in com­bi­na­tion with axi­tinib for the first-line treat­ment of adult patients with advanced renal cell car­ci­no­ma (RCC). The approval was based on pos­i­tive inter­im results from the Phase III Javelin Renal 101 study, which demon­strat­ed that Baven­cio in com­bi­na­tion with axi­tinib sig­nif­i­cant­ly low­ered risk of dis­ease pro­gres­sion or death by 31% and near­ly dou­bled objec­tive response rate com­pared with suni­tinib in patients with advanced RCC regard­less of PD-L1 sta­tus. The study includ­ed patients across Inter­na­tion­al Metasta­t­ic Renal Cell Car­ci­no­ma Data­base Con­sor­tium (IMDC) prog­nos­tic risk groups. Improve­ment in pro­gres­sion-free sur­vival (PFS) was observed across pre-spec­i­fied sub­groups in patients receiv­ing the treat­ment combination.

“There is a high inci­dence of kid­ney can­cer in Europe, and for the most com­mon type, renal cell car­ci­no­ma, we con­tin­ue to need addi­tion­al treat­ment options, par­tic­u­lar­ly for patients with advanced dis­ease, where out­comes are poor­est,” said Pro­fes­sor James Larkin, Con­sul­tant Med­ical Oncol­o­gist at The Roy­al Mars­den NHS Foun­da­tion Trust and Pro­fes­sor at the Insti­tute of Can­cer Research (ICR). “We’ve seen a demon­strat­ed effi­ca­cy ben­e­fit and safe­ty and tol­er­a­bil­i­ty pro­file for avelum­ab in com­bi­na­tion with axi­tinib across all prog­nos­tic risk groups in patients with advanced renal cell car­ci­no­ma, so today’s approval in Europe brings an impor­tant option that can help health­care pro­fes­sion­als opti­mize treat­ment strate­gies across risk stratification.”

In 2018, an esti­mat­ed 136,500 new cas­es of kid­ney can­cer were diag­nosed in Europe, and approx­i­mate­ly 54,700 peo­ple died from the disease.2 Many patients liv­ing with advanced RCC do not go on to receive addi­tion­al treat­ment after first-line ther­a­py, for rea­sons that may include poor per­for­mance sta­tus or adverse events from their ini­tial treat­ment. The five-year sur­vival rate for patients with advanced RCC is approx­i­mate­ly 12%.

“This first Euro­pean approval of an anti-PD-L1 as part of a com­bi­na­tion treat­ment for advanced renal cell car­ci­no­ma builds on our com­mit­ment to bring­ing inno­v­a­tive treat­ment options to patients with hard-to-treat can­cers through our exten­sive Javelin clin­i­cal tri­al pro­gram,” said Rehan Ver­jee, Glob­al Head of Inno­v­a­tive Med­i­cine Fran­chis­es for the Bio­phar­ma busi­ness of Mer­ck. “RCC is the most com­mon form of kid­ney can­cer, account­ing for 90% of diag­noses. We are now work­ing to make Baven­cio in com­bi­na­tion with axi­tinib avail­able for patients with advanced renal cell car­ci­no­ma as quick­ly as possible.”

“The Euro­pean Com­mis­sion approval of Baven­cio in com­bi­na­tion with axi­tinib has the poten­tial to bring even more patients with advanced renal cell car­ci­no­ma a new first-line treat­ment, and it allows us to con­tin­ue to deliv­er on our more than decade-long pas­sion to do more for patients with kid­ney can­cer,” said Andy Schmeltz, Glob­al Pres­i­dent, Pfiz­er Oncol­o­gy. “We thank all of the researchers, doc­tors, advo­cates, patients and their fam­i­lies who helped get us here today, and we will con­tin­ue in our fight against this advanced cancer.”

The EC’s deci­sion fol­lows the U.S. Food and Drug Admin­is­tra­tion (FDA) approval of Baven­cio in com­bi­na­tion with axi­tinib for the first-line treat­ment of patients with advanced RCC in May 2019. A sup­ple­men­tal appli­ca­tion for Baven­cio in com­bi­na­tion with axi­tinib in unre­sectable or metasta­t­ic RCC was sub­mit­ted in Japan in Jan­u­ary 2019.

Addi­tion­al­ly, with this approval, the posol­o­gy sec­tion of the Sum­ma­ry of Prod­uct Char­ac­ter­is­tics for Baven­cio has been updat­ed. The rec­om­mend­ed dose of Baven­cio as monother­a­py is 800 mg admin­is­tered intra­venous­ly over 60 min­utes every 2 weeks. Admin­is­tra­tion of Baven­cio should con­tin­ue accord­ing to the rec­om­mend­ed sched­ule until dis­ease pro­gres­sion or unac­cept­able tox­i­c­i­ty. The rec­om­mend­ed dose of Baven­cio in com­bi­na­tion with axi­tinib is 800 mg admin­is­tered intra­venous­ly over 60 min­utes every 2 weeks and axi­tinib 5 mg oral­ly tak­en twice dai­ly (12 hours apart) with or with­out food until dis­ease pro­gres­sion or unac­cept­able toxicity.