The month ahead: November’s upcoming events

In November, two groups could have a chance to catch their more advanced rivals. Kura and Kyowa Kirin are awaiting an FDA decision on their menin inhibitor ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukaemia; while Bayer could get the nod for sevabertinib in second-line HER2m NSCLC. The companies are chasing Syndax and Boehringer respectively.

Meanwhile, AbbVie and Genmab’s CD20-targeting T-cell engager Epkinly could expand from third into second-line follicular lymphoma. November will also see various scientific and investor meetings, the most prominent of which is SITC, and haematology specialists will get the first glimpse of what’s to come at the ASH conference, with abstracts dropping on Monday.

Kura vs Syndax

Ziftomenib is facing its first FDA decision, while Syndax’s rival menin inhibitor Revuforj was approved last year for relapsed KMT2A-rearranged acute leukaemia, and in October for NMP1m disease.

Kura is no longer pursuing the KMT2Ar niche with ziftomenib monotherapy, but this only accounts for around 10% of AML, compared with 30% for NPM1m. And Kura has long claimed a better safety profile with ziftomenib, particularly on QTc prolongation. Revuforj has a black box warning for both QTc prolongation and differentiation syndrome. With efficacy looking similar, any edge Kura might gain here could be valuable.

Bayer vs Boehringer

Another battle is shaping up in the HER2m NSCLC space, where Boehringer got a second-line FDA nod for Hernexeos in August, and Bayer’s sevabertinib is awaiting a decision based on the phase 1/2 Soho-01 trial.

Hernexeos looks to have slight stronger efficacy: that drug’s label cites a 75% ORR among 71 second-line patients in the Beamion Lung-1 trial, while the most recent data from Soho-01, presented at ESMO, saw a 64% ORR among 81 previously-treated patients.

Hernexeos’s label cautions against liver toxicity, but the drug avoided a more serious black-box warning. The companies are also facing off in front-line HER2m NSCLC, where they recently reported similar data at ESMO from Beamion Lung-1 and Soho-01. Phase 3 front-line studies are also under way.

Epkinly expansion?

AbbVie and Genmab stole a march on their CD20 rivals when they reported positive topline results in August from the Epcore FL-1 study, in second-line follicular lymphoma. The drug already has accelerated approval in third-line disease, so the results could confirm and expand its existing indication.

As for the competition, Roche’s Lunsumio has accelerated approval for Lunsumio in third-line FL, but its second-line Celestimo trial has been delayed until early 2026; it had once been expected to yield data in 2023. And Regeneron hasn’t managed to get its hopeful odronextamab approved in the US, instead receiving two CRLs.

In Epcore FL-1, Epkinly plus Rituxan and Revlimid improved both ORR and PFS versus Rituxan and Revlimid alone, with the partners reporting a 79% reduction in the risk of disease progression or death. The companies hope to present the data at ASH.

Monday’s ASH abstract drop will show if the groups have been successful – unless they’ve grabbed a late-breaker slot, with these abstracts under wraps until 1 December. 

November’s upcoming events

Source: OncologyPipeline.