The month ahead: November’s upcoming events

The dark days are setting in, which can only mean one thing: conferences are coming. November will see various scientific meetings, of which SITC is the most notable, as well as a preview of the big remaining congress this year: regular ASH abstracts are due early in the month, with late-breakers set to follow a few weeks later.Meanwhile, several FDA approval decisions are due: Autolus will see if its Car-T contender obecabtagene autoleucel can join the autologous CD19-targeting crowd, and Merus could find out if its HER2 x HER3-targeting bispecific zenocutuzumab passes muster in the niche of NRG1-positive non-small cell lung and pancreatic cancers.Merus had once hoped to get approval in NRG1-positive patients regardless of tumour type, but this plan was scuppered by the FDA. In any case, the focus for the company is now its anti-EGFR x LGR5 bispecific petosemtamab; Merus has said it needs a partner to commercialise zenocutuzumab.At least zenocutuzumab received priority review from the FDA – this wasn’t the case for Autolus’s obe-cel, a situation probably not helped by the availability of several other autologous, CD19-directed Car-Ts.Meanwhile, Jazz will hope to get the first nod for its HER2 x HER2 bispecific MAb zanidatamab, in second-line HER2-gene-amplified biliary tract cancers. AstraZeneca and Daiichi’s HER2 juggernaut Enhertu isn’t approved here, but is being tested in the first-line phase 3 Destiny-Biliary Tract Cancer-01 study.Zanidatamab is already in a confirmatory trial in biliary tract cancer, Herizon-BTC-302, as well as phase 3 studies in breast cancer (post-Enhertu) and gastroesophageal adenocarcinoma.And Shorla expects a decision on its oral liquid chemo, SH-201.ASH flashWhile SITC takes place in early November, the big excitement next month might come from the unveiling of ASH abstracts. One group that has promised an update is Arcellx, which said in August that it submitted an abstract on the pivotal Immagine-1 trial of its Gilead-partnered BCMA-directed Car-T candidate anitocabtagene autoleucel.The therapy is being tested in fourth-line multiple myeloma, while rival Car-Ts from Johnson & Johnson/Legend (Carvykti) and Bristol Myers Squibb/2seventy bio (Abecma) are now approved for earlier lines.Anito-cel’s unique selling point is its “smaller and simpler” synthetic binding domain that, Arcellx says, could lead to better manufacturability and, potentially, safety versus the incumbents. Investors will be looking for any cases of neurotoxicity, which has been a problem with Carvykti.There are plenty of investor meetings coming in November, too, including the Jefferies London healthcare conference, which is becoming the UK’s answer to JP Morgan. November’s upcoming eventsEventTimingDetailsASH abstracts available online5 NovVirtualBIO-Europe 20244-6 NovStockholmSITC (Society for Immunotherapy of Cancer) meeting6-10 NovHoustonEMUC (European Multidisciplinary Congress on Urological Cancers)7-10 NovLisbonTruist Securities biopharma symposium7 NovNew YorkGuggenheim global healthcare conference11-13 NovBostonUBS global healthcare conference11-14 NovRancho Palos Verdes, CaliforniaCTOS (Connective Tissue Oncology Society) meeting13-16 NovSan DiegoCHMP day14 NovDecisions could come on Regeneron’s linvoseltamab in 4L+ MM (FDA CRL Aug 2024), Sanofi’s Sarclisa in 1L transplant-ineligible MM & AstraZeneca’s Tagrisso in stage III EGFRm NSCLCPoseida cell therapy R&D day14 NovVirtualBioNTech innovation series R&D day14 NovNew YorkObecabtagene autoleucel PDUFA16 Novr/r adult B-cell ALL (Felix trial)Stifel healthcare conference18-19 NovNew YorkWolfe healthcare conference19-20 NovNew YorkJefferies London healthcare conference19-21 NovLondonSNO (Society for Neuro-oncology) meeting21-24 NovHoustonASH late-breaking abstracts available online25 NovVirtualZanidatamab PDUFA29 NovHER2+ve locally advanced/metastatic biliary tract cancer (Herizon-BTC-01 trial)SH-201 PDUFA30 Nov“Certain forms of leukaemia and other cancers”Zenocutuzumab PDUFAAssumed NovNRG1+ NSCLC and PDAC (Enrgy trial)Source: OncologyPipeline.