The month ahead: August’s remaining events

Earnings season is in full swing, and some companies took the opportunity to sneak out bad news. One of these was Regeneron, which disclosed during its second-quarter earnings call last week that the FDA approval decision on the BCMA-targeting T-cell engager linvoseltamab, due by 22 August, would likely be delayed.

The setback doesn’t look too serious: Regeneron said there was an issue with a third-party manufacturer, requiring a reinspection, and added that FDA hadn’t raised any questions about safety, efficacy, or an ongoing confirmatory trial. But the news comes not long after the group got a complete response letter for its other key T-cell engager, odronextamab, and adds another question to Regeneron’s ambitions to become a bispecifics player.

Another big August approval decision concerns Syndax and Incyte’s axatilimab in late-line chronic graft-versus-host disease, based on the uncontrolled Agave-201 study. Still, earlier lines of therapy, where combination studies are planned to start this year, will represent bigger uses. And Syndax was recently hit by its own delay, to the menin inhibitor revumenib.

Possible decisions

Johnson & Johnson could also see the expansion of its EGFR x cMet bispecific Rybrevant, a drug it hopes could eventually bring in sales of $5bn. The product is currently approved for second-line NSCLC with EGFR exon 20 insertion mutations, and J&J is awaiting decisions in first-line and post-Tagrisso EGFR-mutated NSCLC.

In the front line, Rybrevant is being combined with the oral EGFR-TKI lazertinib, where it was tested in the Mariposa study, and in the post-Tagrisso setting J&J is seeking approval alongside chemo, supported by Mariposa-2.

It’s hard to gauge, though, exactly when approvals might come, as J&J doesn’t disclose its PDUFA dates.

It’s also difficult to know when AstraZeneca might see an approval decision on its PD-L1 blocker Imfinzi in the new use of neoadjuvant NSCLC, based on the Aegean study. The product had been expecting an approval decision here last month; however, this was delayed by an adcom, which turned out to be fairly innocuous. It’s possible that a verdict could come in August.

One ruling that doesn’t look likely to happen this month involves BeiGene’s checkpoint inhibitor Tevimbra in an expanded indication, first-line metastatic oesophageal squamous cell carcinoma. BeiGene confirmed during its second-quarter results this week what it had already hinted at in May: the FDA has deferred approval because of a delay in scheduling clinical site inspections.

Tevimbra previously suffered from inspection-related delays, before getting its first US approval in March for second-line oesophageal squamous cell carcinoma.

August approvals

Several drugs have already got the FDA go ahead in August, including Adaptimmune’s engineered T-cell receptor therapy Tecelra, and GSK’s anti-PD-1 MAb Jemperli, which is now available for all first-line endometrial cancer patients, including those with microsatellite stable (MSS) tumours. Jemperli previously had the go ahead for mismatch repair-deficient disease, a setting that recently saw the entrance of AstraZeneca’s Imfinzi.

There was also a first-time approval this week for Servier’s vorasidenib (now branded Voranigo), for IDH-mutant grade 2 astrocytoma or oligodendroglioma, following surgery. The nod, well ahead of the 20 August PDUFA date, came despite two probable cases of Hy’s law in the drug’s registrational Indigo trial.

Servier gained Voranigo via its $1.8bn acquisition of Agios’s cancer portfolio in 2020, and in May Agios signed over most of its royalties on the product to Royalty Pharma. The approval means that Agios will receive $905m from Royalty as well as $200m from Servier in the third quarter. 

August’s upcoming events

Source: OncologyPipeline.