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ALETH / LIFESCI-BRIEF / 2026-09-18 / KEYTRUDA BEATEN ON SURVIVAL IN LUNG CANCER FIRST

Keytruda beaten on survival in lung cancer first

Also this week: NICE recommended Enhertu for the NHS, the FDA approved the first Lutathera equivalent & GSK and Hansoh's B7-H3 drug nearly doubled survival in small cell lung cancer.

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

Browse by day:

Weekend catch-up

AstraZeneca’s Etcamah missed its primary endpoint in untreated advanced breast cancer.

On Friday evening AstraZeneca said the phase 3 SERENA-4 trial of Etcamah (camizestrant) with Ibrance (palbociclib) failed to beat an aromatase inhibitor plus Ibrance on progression-free survival in 1,371 patients with oestrogen receptor-positive, HER2-negative advanced breast cancer who had not been treated for advanced disease. The oral selective oestrogen receptor degrader stays approved in the US, EU and Japan with a CDK4/6 inhibitor for patients whose tumours develop an ESR1 mutation during first-line endocrine therapy, on the SERENA-6 trial.

Akeso’s ivonescimab beat Keytruda on overall survival.

In the phase 3 HARMONi-2 trial in China, ivonescimab monotherapy extended median overall survival to 30.8 months against 22.6 months for Keytruda (pembrolizumab) in first-line PD-L1-positive advanced non-small cell lung cancer (hazard ratio 0.73, p=0.009). Follow-up was 36 months at the 20 August cut-off. The benefit was largest in tumours with PD-L1 expression of 50% or more, where the hazard ratio was 0.58.

HARMONi-2 had already met its progression-free survival endpoint in 2024, which won the drug its Chinese approval. Survival is the harder test, and no drug had cleared it against Keytruda in this setting before. Akeso’s partner Summit Therapeutics holds rights outside China and is running its own phase 3 programme.

GSK and Hansoh’s B7-H3 drug nearly doubled survival in relapsed small cell lung cancer.

In the phase 3 ARTEMIS-008 interim analysis, presented at the World Conference on Lung Cancer in Seoul, risvutatug rezetecan lifted median overall survival to 18.5 months against 10.3 months for topotecan. Hansoh calls it the first randomised phase 3 study anywhere to show a survival benefit for a B7-H3 antibody-drug conjugate in the disease. GSK holds rights outside mainland China, Hong Kong, Macau and Taiwan.

Roche and MediLink’s rival B7-H3 drug cut the risk of death by 54% in the same disease.

The phase 3 TAISHAN-302 trial in China gave Tam-Peli (tambotatug pelitecan) a median overall survival of 13.3 months against 9.4 months for topotecan, with median progression-free survival of 7.4 months against 2.8 and a response rate of 59.1% against 9.7%. Roche licensed the drug from MediLink in January and plans to start global phase 3 trials.

Scholar Rock won FDA approval for the first muscle-targeted SMA treatment.

Isembyld (apitegromab) was cleared for adults and children aged two and over with spinal muscular atrophy who are already on a treatment targeting the SMN2 gene. All existing therapies target the motor neuron, whereas this drug acts directly on muscle. It is the first to demonstrate improved motor function on top of those treatments. In the phase 3 SAPPHIRE trial, Isembyld produced a 2.2-point improvement on the Hammersmith Functional Motor Scale-Expanded after a year, in the main efficacy population of 103 children aged 2 to 12. Scholar Rock also collected a priority review voucher.

Monday 14 September

AstraZeneca and Daiichi Sankyo’s Enhertu added six months of progression-free survival in first-line HER2-mutant lung cancer.

In the phase 3 DESTINY-Lung04 trial, Enhertu reached a median of 14.3 months against 8.3 months for Keytruda plus chemotherapy in 454 patients, cutting the risk of progression or death by 37% (hazard ratio 0.63, p<0.0001). Response rate was 70.0% against 44.5%. At 46.9% maturity there was no observed overall survival benefit, and AstraZeneca pointed to imbalanced use of later therapies. Interstitial lung disease or pneumonitis occurred in 20.8% of Enhertu patients, with four Grade 5 events.

The FDA approved the first radioligand equivalent for GEP-NETs.

Curium’s Bexlutry (lutetium Lu 177 dotatate) was cleared for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. It went through the 505(b)(2) pathway against Novartis’s Lutathera, supported by published evidence and bridging data showing a similar biological and chemical profile.

Sanofi proposed handing 20 older medicines and three plants to Cheplapharm for a 26.4% stake.

The German family-owned group would take over products including Lovenox/Clexane (enoxaparin), excluding the US, and manufacturing sites in Hungary, Singapore and France. The portfolio transfer is planned to begin in Q1 2027 and the deal is expected to complete by Q3 2027, subject to employee consultation, regulatory approvals and customary closing conditions. Sanofi takes equity rather than cash, and says the deal will not change its 2026 guidance.

Electra Therapeutics set IPO terms targeting $296.6m net at the midpoint.

The company filed to sell 21.67m shares at $14 to $16 on Nasdaq under the ticker ETRA, which would raise $296.6m net at the midpoint and $341.9m if underwriters take their full option. Lead candidate ipsoprubart is a pan-SIRP antibody in a registrational programme for secondary haemophagocytic lymphohistiocytosis.

Novo Nordisk will be known as Novo day to day.

The company rebranded around the single name Novo and the line “Lasting Health Starts Now”, and set out a new internal culture code. Novo Nordisk A/S remains the legal company name. A fuller strategy update comes at its Capital Markets Day in London on 21 September.

Cellectis dropped its two allogeneic CAR-T programmes to become an in vivo gene editing company.

The board approved the change on 11 September. Cellectis will drop lasme-cel and eti-cel and look for partners for them, and put its money behind .HEAL-101, an in vivo base editor targeting APOC3 in severe hypertriglyceridaemia, and .HEAL-201, an epigenetic editor targeting PCSK9 in severe hypercholesterolaemia. It keeps its existing cell therapy partnerships with AstraZeneca, Allogene, Servier and Iovance, and the combined actions are designed to extend its cash runway into H2 2028.

The FDA held a public hearing on how psychedelic medicines should be used.

The agency asked for views on the therapeutic use of psychedelics in supervised and supportive settings, with a first approval in the class now close. Access dominated: who would be allowed to administer such a drug, and how that would be credentialled. Clinical psychologist Geoff Bathje told the hearing he had been “disappointed to see the FDA minimize the importance of the therapeutic relationship in psychedelic research for the sake of isolating drug effects in clinical trials“.

Definium’s LSD therapy won a third phase 3 trial in 12 weeks.

In the 245-patient Panorama study, DT120 cut Hamilton Anxiety Rating Scale scores by 9.8 points at week 12 against 4.7 for placebo. Definium has a pre-NDA meeting in Q4 2026, with a filing planned for H1 2027, having also won in anxiety in the Voyage trial and in major depressive disorder in June.

Tuesday 15 September

GSK will pay up to $750m for a Chimagen trispecific T-cell engager in multiple myeloma.

GSK would acquire full global rights on closing for an upfront fee, with the rest tied to development and commercial milestones, and expects to start phase 1 trials in 2027. The agreement is subject to customary closing conditions. It is the second asset GSK has taken from the Chinese biotech, after CMG1A46, a CD19 and CD20 dual-targeted engager already in phase 1.

Vera Therapeutics’ Trutakna held kidney function steady for two years in IgA nephropathy.

The final efficacy analysis of the phase 3 ORIGIN 3 trial, in 428 patients, met every prespecified endpoint. Trial investigator Richard Lafayette said the result showed “a significant reduction in risk of composite kidney disease progression, true stabilization of eGFR, and a favorable safety profile through two years“. Trutakna holds accelerated approval on proteinuria reduction. Vera plans to file for full approval in Q4 2026.

The FDA opened applications for a pilot meant to speed up first-in-human trials.

The Expedited Investigational New Drug (IND) Pilot pairs drug sponsors with qualified research institutions and lets the agency review parts of an application on a rolling basis before the full filing. The FDA says first-in-human trials can take up to two years to complete in the US against much faster timelines in China and Australia. Applications close on 30 October, and 8 to 10 sponsor pairs will be chosen.

Mayo Clinic and Thermo Fisher Scientific launched Precure to map disease before symptoms appear.

The new company will build a biomedical dataset out of one of the largest human multi-omics data-generation efforts to date, joining proteomic, genomic and longitudinal clinical data. Mayo brings biospecimens and longitudinal de-identified clinical data, Thermo Fisher the proteomics platforms.

Wednesday 16 September

Novo Nordisk signed an AI discovery deal with Anthropic.

Novo will test Claude Science on specific research and development workflows, starting with scientific problems where it thinks the two companies together can do most, and will use Anthropic’s frontier models for AI-driven software development.

Anthropic chief executive Dario Amodei said increasing AI capability “brings with it the potential to compress a century’s worth of biological and medical breakthroughs into a decade“. No financial terms were given.

Sling Therapeutics raised $123m to advance an oral thyroid eye disease drug in phase 3.

Forbion led the series C, with TPG Life Sciences Innovations and Sectoral Asset Management taking part. Linsitinib is an oral IGF-1R inhibitor aiming to compete against the injectable drugs used now, and its global phase 3 ORBIT trial has started.

ByteDance’s AI drug discovery unit closed a $290m round.

Reuters reported the first outside funding for Anew Labs since its spin-off from the Chinese technology group.

Thursday 17 September

NICE recommended Enhertu for NHS use in final draft guidance.

Around 1,000 people a year with HER2-low advanced or metastatic breast cancer whose disease has progressed can now be offered Enhertu on the NHS. It had been the only breast cancer drug NICE could not recommend since 2018, with 25 others recommended in that period. NICE said a solution was agreed “following changes made to NICE methods as part of the UK/US Pharmaceutical Pricing Agreement“.

The FDA approved Ultragenyx’s Fayuvi, the first treatment for Sanfilippo syndrome type A.

The one-time AAV gene therapy is cleared for the neurological effects of mucopolysaccharidosis type IIIA in children whose neurodevelopment is still preserved, on the Transpher A registration trial and follow-up running to nearly eight years. In the modified intention-to-treat population, Fayuvi produced a 23.5-point higher Bayley-III cognitive score than natural history. The FDA had refused the application in July 2025 over manufacturing controls and facility inspection findings. It is the company’s sixth approval, and came with a priority review voucher.

Bayer’s Kerendia won the first new US approval in 30 years for kidney disease in type 1 diabetes.

The FDA cleared Kerendia (finerenone) under priority review to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, a reduction expected to lower the risk of sustained kidney function decline and end-stage kidney disease. The FINE-ONE results let Bayer bridge Kerendia’s outcomes evidence from type 2 diabetes. It is the drug’s third indication.

Two more private biotechs lined up reverse mergers onto Nasdaq.

Lisata Therapeutics acquired Marea Therapeutics and agreed a concurrent private placement expected to raise about $225m, picking up MAR001/005 in severe hypertriglyceridaemia, now in phase 2b, and MAR002 in acromegaly. Separately, Aethlon Medical signed a definitive merger agreement with North Immunology, subject to closing conditions, alongside an oversubscribed $180m placement funding NOR-101, an IL-13 by IL-18 bispecific antibody for atopic dermatitis, into the clinic. The combined company will take the North Immunology name.

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