The 2026 European Society for Medical Oncology (ESMO) congress is drawing to a close but has been packed with potentially paradigm-shifting readouts across several solid tumour indications, with lung cancer remaining a key focus.
While there are now several treatments approved for various forms of lung cancer, many patients with specific genotypes still face significant unmet needs – meaning there is a strong need for novel drugs and combinations to address these challenges and improve outcomes.
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One of these companies is Amgen, which is running a wide development programme for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab). During a Presidential Symposium at ESMO 2026, the Californian pharma giant presented positive data from the DeLLphi-305 (NCT06211036) – a study that pitted a combination of Imdelltra and AstraZeneca’s Imfinzi (durvalumab) with Imfinzi alone in patients with frontline extensive-stage small-cell lung cancer (ES-SCLC).
Through this study, researchers uncovered the benefits of this novel combination, with Imfinzi-Imdelltra cutting the risk of death by 58% compared with Imfinzi alone at a median follow-up of 15.9 months – a feat which William Blair analysts called “impressive”. For patients receiving the combination, the median overall survival (OS) was 21.1 months – an 8.4-month improvement over Imfinzi (12.7 months).
Meanwhile, the duo of drugs also reduced the risk of disease progression or death by 66% over Imfinzi alone, with patients given Imfinzi-Imdelltra reaching a median progression-free survival (PFS) rate of 7.4 months over 1.9 months in the Imfinzi monotherapy arm. The treatment benefits were consistent across all prespecified subgroups – including patients whose cancer had spread to the brain or liver.
These results drop as outcomes remain poor within the ES-SCLC patient population, with researchers estimating the disease’s five-year survival rate as between 2.8% and 7%.
According to AstraZeneca’s SVP of late development oncology and oncology R&D, Leora Horn, the DeLLphi-305 outcomes will “redefine treatment standards” for patients with ES-SCLC, while reinforcing Imfinzi’s potential as “the backbone immunotherapy in this setting”.
William Blair analysts echoed this sentiment, adding that this readout opens a “significant market opportunity for Imdelltra.”
GlobalData analysis pegs the benchmark for success with this therapy as Roche’s Tecentriq (atezolizumab) and Jazz Pharmaceuticals’ Zepzelca (lurbinectedin). The FDA approved that combination in October 2025 on the basis of the Phase III IMforte trial.
Roche’s divarasib outshines first-generation drugs in Phase III
Another readout grabbing the attention of patrons at ESMO 2026 was that of Roche’s selective KRAS G12C inhibitor, divarasib. At the conference, the Swiss pharma company presented data from the Phase III Krascendo I trial (NCT06497556), which looked at the safety and efficacy of divarasib compared with approved, first-generation KRAS G12C inhibitors such as Amgen’s Lumakras (sotorasib) or Bristol Myers Squibb’s (BMS) Krazati (adagrasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). Patients had received between one and three lines of prior systemic therapy.
At a presidential symposium, Roche debuted results revealing that divarasib had bested its first-generation counterparts – significantly bolstering PFS from 9.8 months versus 5.7 months in the comparator treatment arms at a median follow-up of 14.3 months, while also offering a significant 5.7-month improvement in OS over Krazati and Lumakras. Median OS with Roche’s therapy was 17.7 months compared to an average of 12 months for the control therapies.
Meanwhile, a lower 24.6% of patients given divarasib experienced Grade 3 and 4 treatment-emergent adverse events (TEAEs) compared with 34.5% in the control arm, and hepatotoxicity was also lower in the divarasib arm, leading the Institut Gustave Roussy’s Prof Benjamin Besse to note that divarasib could be “more immunotherapy (IO) friendly than sotorasib”, which is sometimes linked to liver toxicity following IO treatment.
“Results from Krascendo 1 trial indicate that the higher potency of divarasib could translate into a new standard of care,” commented Besse, adding that the therapies that emerge as future leaders in this space will likely display differentiated toxicity.
With a second-line success in the bag, Roche will now look to the frontline potential of divarasib in this indication through the Krascendo 2 trial (NCT06793215), which is evaluating the drug in combination with MSD’s Keytruda (pembrolizumab) versus Keytruda and chemotherapy in the KRAS G12C mutant NSCLC population.
This comes as therapies directed at the RAS pathway garner significant attention from both the industry and physicians alike, as many tout their potential to treat cancers traditionally linked to poor outcomes. Recently, the landmark pancreatic cancer approval of Revolution Medicines’ pan-RAS(ON) inhibitor, Rasonque (daraxonrasib) – which is currently in development for RAS-mutant NSCLC –shook up the field, as the drug almost doubled OS in this setting.
MSD’s sac-TMT plus Keytruda bests SoC in PD-1L-negative patients
With the antibody-drug conjugate (ADC) modality firmly in the spotlight at this year’s ESMO congress, many tuned in to new data from the Phase III OptiTROP-Lung06 study (NCT06711900), which explored the potential of MSD and Kelun-Biotech’s TROP2-targeted ADC, sacituzumab tirumotecan (sac-TMT) alongside Keytruda versus Keytruda plus platinum-based chemotherapy in frontline, PD-L1-negative, metastatic non-squamous NSCLC.
During an oral presentation at the event, the companies revealed that the ADC-IO combination significantly prolonged PFS, with the risk of disease progression or death dropping 51% in the sac-TMT-Keytruda arm. While OS had not yet been reached at the interim analysis, the trend is supporting the investigational arm.
Patients given sac-TMT and Keytruda also had more durable responses to treatment than those given Keytruda and chemotherapy, with the median duration of response (DoR) sitting at 13.6 months versus 6.8 months.
In addition, the targeted combination appeared to be more tolerable than Keytruda and chemotherapy, with researchers observing fewer TEAEs of Grade 3 or higher in the former group, as well as fewer TEAEs that led to dose reduction or permanent treatment discontinuation.
According to Caicun Zhou, director of oncology at Shanghai East Hospital, Tongji University, these results further highlight the clinical benefits of sac-TMT alongside Keytruda in first-line PD-L1-negative EGFR/ALK-negative advanced non-squamous NSCLC.
“Together with the OptiTROP-Lung05 results previously presented at 2026 ASCO, this combination regimen has shown PFS benefit in patients with NSCLC without actionable genomic alterations, regardless of PD-L1 expression, providing new Phase III evidence as first-line treatment,” Zhou commented.
Currently, MSD and Kelun are evaluating sac-TMT’s potential in the clinic across a wide range of solid tumour indications – including gynaecologic cancers like endometrial and ovarian, as well as various forms of breast, lung, gastrointestinal and genitourinary cancers.
Analysts at GlobalData, parent company of Clinical Trials Arena, predict that sac-TMT, if approved, will secure its blockbuster status by 2030, with the drug’s sales expected to top $3.6bn in 2032 at the end of the forecast period.
BioNTech’s pumitamig shows advanced NSCLC potential
Another modality grabbing ESMO attendees’ attention is the bispecific antibody, with many drugs focused on validated targets like PD-L1 and VEGF currently making their way through the clinical pipeline.
One of the companies pursuing development with this modality is BioNTech with its PD-L1 x VEGF-A-targeting candidate, pumitamig. At ESMO, the German pharma company presented first data from the Phase II ROSETTA-Lung107 trial (NCT06841055), which is looking at the drug’s potential alongside docetaxel in patients with metastatic NSCLC who progressed after IO and chemotherapy.
Thus far, BioNTech notes that pumitamig has displayed “encouraging responses” in both squamous and non-squamous NSCLC across levels of PD-L1 expression and various histologies, with the confirmed objective response rate (ORR) in the 30 efficacy-evaluable patients being 36.7%.
In this study, the median PFS was 6.9 months, while standard-of-care (SOC) docetaxel generally delivers a median PFS of around 3.6-3.9 months for non-squamous and squamous metastatic NSCLC, respectively, after prior exposure to IO and chemotherapy.
According to Jefferies analysts, ROSETTA-Lung107 results show efficacy that “looks broadly consistent with ivonescimab”.
Akeso and Summit Therapeutics’ ivonescimab is currently under review by US regulators for the treatment of a specific type of NSCLC.
“Activity was seen across PD-L1 expression levels, though we’ll caveat the small sample size, and safety looks broadly consistent with prior ivonescimab experience,” the analysts commented. “Overall, we think the early data is encouraging, though randomised validation is still needed,” they added.
