Several abstracts and data presentations on emerging clinical research in non-small cell lung cancer prompted expert interest and discussion at the American Society of Clinical Oncology (ASCO) 2026, held 29 May–2 June, 2026.
Here is a look at the potential impact of two such presentations; one focused on the Akeso and Summit Therapeutics’ PD-1/VEGF-targeting bispecific antibody ivonescimab, and another focused on the efficacy of Eli Lilly’s RET-targeting tyrosine kinase inhibitor Retvemo (selpercatinib).
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Akeso and Summit demonstrate a significant reduction in death for ivonescimab
Akeso presented results for the Phase III HARMONi-6 clinical trial during the plenary session. HARMONi-6 evaluated Idafang (ivonescimab), a PD-1 and VEGF-A–targeting bispecific antibody, in combination with chemotherapy compared to BeOne Medicines’ Tevimbra (tislelizumab), a PD-1 monoclonal antibody, in combination with chemotherapy, in patients with previously untreated advanced or metastatic squamous non-small cell lung cancer (NSCLC), conducted at 50 sites across China. Approximately 25–30% of patients with NSCLC have a squamous histology, which has a generally poor prognosis. Akeso has received two NMPA approvals for Idafang: the first in epidermal growth factor receptor (EGFR)-mutated non-squamous metastatic NSCLC post-treatment with an EGFR-targeting tyrosine kinase inhibitor, and the second as a first line in PD-L1–positive locally advanced or metastatic NSCLC, negative for EGFR and anaplastic lymphoma kinase (ALK) mutations. Summit holds rights to market and develop Idafang from Akeso in the US, Canada, Europe, Japan, Latin America, the Middle East, and Africa.
In HARMONi-6, patients who received Idafang + chemotherapy achieved a median overall survival (OS) of 27.9 months (95% confidence interval [CI]: 27.9, not estimable [NE]), compared to 23.7 months (95% CI: 20.11, NE) for patients who received Tevimbra, a 34% reduction in the risk of death (hazard ratio [HR]: 0.66, 95% CI: 0.50, 0.87). Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 69.2% of patients in the Idafang arm versus 58.9% of patients in the Tevimbra arm. Discontinuations were low, with only 5.3% of patients discontinued Idafang due to TRAEs compared to 4.5% of patients receiving Tevimbra. VEGF-related events occurred more frequently in the Idafang arm than the Tevimbra arm, with 24.8% of patients experiencing any grade hemorrhage compared to 12.1% for Tevimbra. TRAEs leading to death were comparable across both arms, 3.8% for Idafang and 4.2% for Tevimbra.
These results drew a mixed reception. There are serious questions about the trial’s translatability to a global squamous NSCLC patient population. Patients over the age of 75 were excluded, yet the average age of an American lung cancer patient is 70, and historically VEGF inhibitors carry higher toxicities in these older patient populations. The proportion of female squamous NSCLC in China is lower than the global average, 10% compared to 20% globally, and this is reflected in the HARMONi-6 patient population. A confirmatory global Phase III trial, HARMONi-3, is underway, evaluating ivonescimab + chemotherapy versus pembrolizumab + chemotherapy in first-line (1L) advanced squamous and non-squamous NSCLC. BMS/BioNTech and Pfizer also presented data of their VEGF-PD-(L)1 bispecifics, pumitamig and SSGJ-707, in 1L squamous NSCLC at ASCO 2026, but OS was not yet mature in both cases. Akeso and Summit are ahead and are likely to gain first-in-class FDA approval of a PD-(L)1 and VEGF bispecific in NSCLC.
A further competitive threat comes from antibody-drug conjugate and PD-(L)1 antibody combinations, such as AstraZeneca and Daiichi’s Datroway (datopotamab deruxtecan) with Imfinzi (durvalumab) or Merck & Co’s sacituzumab tirumotecan in combination with Keytruda (pembrolizumab), whose Phase III OptiTROP-Lung05 trial presented positive PFS results at ASCO 2026.
First-line NSCLC is a highly competitive disease setting, and near-term readouts across these programs will shape the NSCLC treatment landscape. According to GlobalData’s analyst consensus forecast, Idafang is estimated to reach $11bn in global sales in 2032, while pumitamig and SSGJ-707 are projected to reach $3.2bn and $710m, respectively, in the same year.
Eli Lilly advances Retevmo into adjuvant RET fusion-positive NSCLC
Eli Lilly presented results from the Phase III LIBRETTO-432 trial of Retevmo (selpercatinib), a rearranged during transfection (RET) targeting tyrosine kinase inhibitor (TKI) in early-stage (IB–IIIA) RET fusion-positive (RET+) non-small cell lung cancer (NSCLC) in the adjuvant setting post-surgery, at the plenary session at ASCO 2026.
RET fusions are a rare oncogenic driver alteration within NSCLC, accounting for 1–2% of all patients, and less than 1% in many other solid tumours such as colorectal cancer or breast cancer. Retevmo is currently indicated for first-line metastatic RET+ NSCLC and for all RET+ solid tumours without other satisfactory treatment options. Despite the broad tumour-agnostic approval, uptake of Retevmo has been limited due to the rarity of the mutation and the requirement of a companion diagnostic to detect it. Lilly hopes that the results of this trial will enable the company to significantly expand the label and therefore increase mutation testing rates more broadly.
A total of 151 patients were enrolled in this trial and randomised 1:1 to either Retevmo or placebo for three years post-surgery. Although stage IB patients were enrolled, only stage II–IIIA patients were evaluated in this analysis. Median event-free survival (EFS) was not reached in the Retevmo arm and was 31.8 months in the placebo arm (hazard ratio [HR], 0.172; 95% confidence interval [CI], 0.058, 0.509; p=0.0003). Two-year EFS was 91.5% for Retevmo compared to 61.1% for the placebo. Three deaths were observed in the trial, all in the placebo arm due to disease progression. Of patients on Retevmo, 66.7% of patients experienced grade 3 and above treatment-emergent adverse events (TEAEs) compared to 23.7% of patients receiving placebo. This high level of TEAEs led to a significant proportion of patients on Retevmo discontinuing treatment (17.3%), indicating that the dose may be too high or treatment may have continued for too long.
This positive trial data will add Retevmo to the available treatment options in adjuvant NSCLC, currently limited to immunotherapy such as Merck and Co’s Keytruda (pembrolizumab), which is less effective in patients with driver mutations such as RET fusions, or TKIs targeting epidermal growth factor receptor such as AstraZeneca’s Tagrisso (osimertinib) or Pfizer’s Alecensa (alectinib). A necessary step for these results to have the maximum benefit for patients would be for genetic testing of RET fusions to become more prevalent for patients with early-stage NSCLC. Retevmo’s main competitor, Rigel’s Gavreto (pralsetinib), has been commercially unsuccessful and is not in trial currently in the adjuvant setting, leaving Lilly to monopolise this small patient population. GlobalData’s analyst consensus forecast projects Retevmo to gain $665m in global sales in 2032 while Gavreto reaches $365m in the same year.
