Amgen’s blockbuster hopeful Lumakras sees slower than expected sales in latest data, analyst says – Endpoints News

It’s been on­ly about one year since Am­gen’s KRAS-tar­get­ed NSCLC drug Lumakras has been mar­ket­ed in the US, and al­ready an­a­lysts are warn­ing of wan­ing sales for the block­buster hope­ful.

A re­port from SVB Se­cu­ri­ties on Mon­day said Lumakras’ Q2 sales didn’t come in as high as ex­pect­ed, with the an­a­lysts low­er­ing US sales pro­jec­tions by 8%, from $60 mil­lion to $55 mil­lion, for the last quar­ter.

Al­so known as so­tora­sib, the drug won ap­proval last May to treat types of non-small cell lung can­cer with the KRAS G12C mu­ta­tion, beat­ing com­peti­tor Mi­rati Ther­a­peu­tics to the reg­u­la­to­ry fin­ish line. At the time, an­a­lysts pre­dict­ed the drug would se­cure more than $1 bil­lion in peak sales, with a list price of $17,900 a month.

But ac­cord­ing to this lat­est re­port, an­a­lysts took a look at script da­ta from IQVIA and not­ed that “script growth” seemed to be well be­low the con­sen­sus es­ti­mates, which were pro­ject­ed to grow 30% se­quen­tial­ly from Q1 to Q2.

That said, the an­a­lysts re­vised their es­ti­mates:

We are low­er­ing our 2QE US sales from 25% seq growth ($60mm) to 15% se­quen­tial growth $55mm. The rea­son we are not low­er­ing it more is that Lumakras had a 3% US price in­crease on Ju­ly 1 which could have yield­ed some ex­tra whole­saler buy­ing in June. Our 2Q glob­al Lumakras sales est is $72mm, 8% be­low cons’ $78mm. Our full-year 2022 glob­al sales est. is $326mm, 9% be­low con­sen­sus $347mm.

An Am­gen spokesper­son dis­missed the con­cerns, telling End­points News that Am­gen is “pleased with the launch progress of Lumakras.” How­ev­er, Am­gen did point out that it is an­gling to try and im­prove up­take by “en­sur­ing that physi­cians writ­ing sec­ond line pre­scrip­tions (where Lumakreas is cur­rent­ly in­di­cat­ed) have ac­cess to re­view KRAS G12C test re­sults, for pa­tients that progress be­yond first line (with the goal of con­vert­ing high test­ing rates in­to ad­di­tion­al Lumakras pre­scrip­tions in sec­ond line).”

Be­yond that, SVB al­so not­ed an FDA-re­quired post-mar­ket­ing study to com­pare two dif­fer­ent dos­es of so­tora­sib as doc­tors have ques­tioned if the cur­rent dose is cor­rect. The re­sults from that study are ex­pect­ed to read out by year’s end, as the an­a­lysts write,

In pre­sen­ta­tions and in our dis­cus­sions with KOLs [key opin­ion lead­ers] around AS­CO, some physi­cians raised the ques­tion of whether KRAS(G12C) in­hibitors are be­ing dosed prop­er­ly, es­pe­cial­ly giv­en on­go­ing com­bi­na­tion tri­als.

An Am­gen spokesper­son told End­points that the post-mar­ket­ing study was orig­i­nal­ly tak­en up to see if there was an im­proved risk ben­e­fit with Lumakras at a low­er dose as part of the FDA’s on­col­o­gy-fo­cused Pro­ject Op­ti­mus. How­ev­er, Am­gen still touts that the drug is safe and ef­fi­ca­cious, point­ing to two-year fol­low-up da­ta that the phar­ma pre­sent­ed at AACR ear­li­er this year.