#ASCO21: J&J busts out a small update for its antibody-TKI combo in lung cancer — whetting appetites as FDA thinks it over
In a red-hot EGFR-mutated non-small cell lung cancer market, Johnson & Johnson thinks it could have a leader in its bispecific antibody amivantamab. But as competitors crowd in, J&J is looking to back up its case for approval, and it’s rolling out just a taste of that data to back its case in rare mutations.
A combination of J&J’s EGFR/MET bispecific antibody amivantamab and small-molecule TKI drug lazertinib posted a median duration of response of 9.6 months in patients with NSCLC with exon 19 deletion or L858R mutation that hadn’t previously undergone chemo but previously failed on AstraZeneca’s Tagrisso, according to cohort data from the Phase I/II CHRYSALIS study set to be presented at ASCO.
It’s a meager update for J&J’s combo after the drugs posted a 100% complete response — and whet investors’ appetites — at last year’s ESMO for EGFR-mutated NSCLC patients who were treatment-naive. In the relapsed setting, a 45-patient cohort hit a 36% confirmed response rate with 1 complete response and 15 partial.
The drugmaker filed for approval in the broader patient population back in December.
Patients in this combo cohort were also genetically tested for EGFR- or MET-based tumor resistance, with 17 patients identified as having one or both resistance mechanisms. Of those, the overall response rate was 47% — higher than the combo cohort on the whole — with a median duration of response of 10.4 months. The clinical benefit response rate was 82% with a median PFS of 6.7 months.
Even more impressive, for the 10 patients in the cohort whose tumors stained high for both MET and EGFR, the overall response rate was 90%. The company said it planned to lean on genetic testing in order to locate patients with the highest chance of benefitting from the amivantamab-lazertinib combo in the Phase III MARIPOSA study currently ongoing.
J&J is primarily setting up amivantamab for exon 20 mutations, which have few treatment options and have become somewhat of an arms race for Big Pharma. On Wednesday, Takeda rolled out its own data set for a next-gen TKI inhibitor looking at the same population.
Looking at the battle against approved and potential TKI head-on, J&J also rolled out “indirect treatment comparison” showing the drug posted a 10-month higher OS compared with patients treated with real-world therapies such as TKIs and checkpoint inhibitors. It’s all part of an effort, J&J said, to highlight the huge unmet clinical need in NSCLC that other players haven’t been able to meet.