As experts from all fields of oncology gather for the 2026 American Society of Clinical Oncology (ASCO) Congress in Chicago, many are turning their attention to key indicators in the area of lung cancer, the leading cause of cancer incidence and death worldwide, according to the World Health Organization (WHO).
With several targeted treatments underway for various lung cancer subtypes, a number of exciting results have already been presented at the event. Pharmaceutical Technology presents highlights, including reports from key players such as Johnson & Johnson (J&J), Pfizer, Bristol Myers Squibb (BMS) and others.
The bispecific drug from BMS and BioNTech has a high response rate.
In a highly anticipated report, BMS and its partner, BioNTech, presented interim data from a Phase II study of the PDL-1/VEGF bispecific drug, pumitamiga, obtained as part of the global Phase II/III ROSETTA Lung-02 study (NCT06712316), which is investigating the potential of the drug in combination with chemotherapy in the treatment of first-line non-small cell lung cancer (NSCLC).
Among the 40 patients enrolled in this part of the study and evaluable for treatment response, with squamous cell or non-squamous cell disease, the overall response rate (ORR) was 70%, with two and 26 patients achieving a complete and partial response, respectively. The highest ORR was observed in the squamous cell carcinoma group: nine of 11 (81.8%) patients achieved this result at a dose of 1400 mg.
While grade 3 or higher adverse events (AEs) were reported in 44,2% patients, only eight cases (18,6%) were considered related to pumitamig, which, as Jefferies analysts note, «is numerically lower than the ~23% discontinuations due to AEs observed with the Keytruda (pembrolizumab) combination.».
In a research note, the analysts added that early data for pumitamig as a first-line treatment for NSCLC look «as good» as data for the late-stage candidate from Merck & Co. and Kelun Biotech, ivonescimab, a PD-1/VEGF inducer that has gained attention after being selected as an abstract for a plenary session at ASCO 2026. «We currently see no clear difference in efficacy or safety between the various PD-(L)1xVEGF therapies and continue to believe that long-term differences will depend on combinations with new ADCs that may expand the therapeutic window,» they stated.
This comes as Pfizer's competing PD-L1/VEGF blocker PF-08634404 showed a confirmed objective response rate (cORR) of 64-75% in both squamous and non-squamous cell lung cancers, regardless of PD-L1 status, in a Chinese study as first-line treatment for non-small cell lung cancer.
Kelun impresses with lung cancer data package.
While all eyes were on Kelun and MSD's key ivonescimab study results, Kelun also announced its intention to apply in China for approval of its selective RET inhibitor, lunbotinib fumarate, based on results from a pivotal study in patients with RET-positive non-small cell lung cancer.
In a phase II clinical trial involving 163 previously treated and treatment-naive patients, lunbotinib fumarate demonstrated confirmed objective response rates (ORRs) of 81.3% and 87.1% in treatment-naive and treatment-experienced patients, respectively. While the median progression-free survival (PFS) has not yet been reached in the treatment-naive group, it was 27.5 months among treatment-experienced patients.
In addition to lunbotinib fumarate's potential to slow disease progression in the overall study population, the RET inhibitor also demonstrated efficacy in the treatment of central nervous system (CNS) metastases, achieving an intracranial response rate (ICR) of 30% among 40 patients with brain metastases.
Patients also tolerated lunbotinib fumarate fairly well, with most adverse events being grade 1 or 2, and only 1,2% patients discontinued treatment due to adverse events.
Kelun will now apply to China's National Medical Products Administration (NMPA) for approval of lunbotinib fumarate for the treatment of RET-positive non-small cell lung cancer, while UK biotech Ellipses Pharma will continue to explore the drug's potential in a global Phase II clinical trial (NCT05443126).
If approved globally, it would join tyrosine kinase inhibitors (TKIs) such as Eli Lilly's Retevmo (selpercatinib) and Roche and Blueprint Medicines' Gavreto (pralstinib) in the RET-positive non-small cell lung cancer market.
J&J is evaluating the potential of Rybrevant-Lazcluze in a subgroup of patients with atypical EGFR mutations.
Along with results from studies of promising drugs, J&J presented data on the combination of ribrevant (amivantamab) and lazcluz (lasertinib) in EGFR-mutated non-small cell lung cancer, seeking to strengthen the drug's position in this subgroup of patients.
At ASCO 2026, the company presented updated, positive results from the open-label Phase I/Ib CHRYSALIS-2 study (NCT04077463), which is evaluating the potential of this drug pair in patients with atypical EGFR mutations.
Although J&J previously published data on the objective response rate (ORR), the primary endpoint of the trial, the major pharmaceutical company presented new overall survival (OS) data, showing that the median OS was nearly three and a half years. After three years, the median OS was 551 TP3T, and after four years, 461 TP3T patients were alive.
Ribrevant-Lazcluzé also demonstrated stable clinical activity in subgroups with atypical EGFR mutations. Patients generally continued treatment for a long time: 41% received Ribrevant treatment for two years or more. This is partly due to the drug's safety and tolerability, with the majority of adverse events being grade 1 or 2.
These findings are particularly important for 10-20% patients with atypical EGFR mutations, as they tend to have worse outcomes than people with common mutations.
According to Joel Neel, principal investigator of the CHRYSALIS-2 study and a professor of medicine at Stanford University, the results of this study "indicate the potential for longer-term disease control," and the long-term results of the study could change the way health care providers treat this subtype of lung cancer.
Regulators in the US, Europe, and the UK have approved Rybrevant-Lazcluze for the treatment of advanced or metastatic non-small cell lung cancer with deletions in exon 19 of the EGFR gene or L858R substitution mutations in exon 21.
Pfizer's Lorbrena demonstrates longest progression-free survival yet in non-small cell lung cancer.
Like J&J, Pfizer sought to demonstrate the potential of its drugs, including the ALK inhibitor Lorbrena (lorlatinib). At ASCO 2026, Pfizer presented seven-year data from the Phase III CROWN trial (NCT03052608), which compares Lorbrena with its predecessor, Xalkori (crizotinib), in patients with previously untreated ALK-positive advanced or metastatic non-small cell lung cancer.
After seven years, the probability of patients surviving without disease progression was 55% compared with 3% in the Xalkori treatment group, while the median progression-free survival assessed by the investigators had not yet been reached at this point for patients receiving Lorbren.
The researchers also found that the drug could prevent and control brain metastases, reducing the risk of developing intracranial disease progression in 94%.
However, Jefferies analysts note that the drug's central nervous system toxicity is a "key weakness": 34% patients required dose reductions, and 5% discontinued treatment due to this factor.
In a statement, Tony Shu-Kam Mok, principal investigator of the CROWN project and head of the Department of Clinical Oncology at the Chinese University of Hong Kong, said: «Observing this level of long-term benefit from once-daily oral therapy, both in terms of sustained improvement in progression-free survival and prevention of brain metastases… highlights the significance of these results for the lung cancer patient community.».
The article "ASCO26: Key Indicators in Lung Cancer" was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.
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