At the conference, AstraZeneca and Daiichi Sankyo will present their case for Dato-DXd in NSCLC, while BioNTech and Merus will reveal promising mid-stage data for their respective cancer candidates.
At the upcoming 2024 Asia Congress of the European Society for Medical Oncology, to be held this coming weekend in Singapore, AstraZeneca and Daiichi Sankyo will present consolidated data for their investigational antibody-drug conjugate datopotamab deruxtecan in non-small cell lung cancer.
Joining the powerhouse partners are BioNTech and Merus, which are advancing novel therapies for solid tumors and head and neck cancer, respectively.
BioNTech Touts ‘Competitive Early Profile’ for ADC in Metastatic Solid Tumors
BioNTech’s antibody-drug conjugate (ADC) BNT324 is in a Phase I/II study for solid tumors, preliminary efficacy findings from which will be presented at ESMO Asia 2024 on Friday.
According to the abstract, shared by BMO Capital Markets analyst in an investor note last week, BNT324 elicited an unconfirmed overall response rate (ORR) of 28.6% and a disease control rate of 83.1%. These included 22 patients achieving partial response and 42 reaching stable disease out of 77 participants with evaluable data.
In the subset of patients with small cell lung cancer, unconfirmed ORR was 45.5%, which appeared to improve even further in those who had prior immuno-oncology and topotecan exposure.
As for safety, more than 90% of patients experienced treatment-emergent adverse events. Over 80% of the toxicities were considered related to the treatment, while around 42% were at least grade 3. Twelve patients needed dose reductions due to side effects, and seven dropped out.
Developed in partnership with DualityBio, BNT324 is a next-generation ADC candidate that targets the immune checkpoint B7-H3 protein and carries a topoisomerase I inhibitor payload. Once bound to its target, BNT324 is internalized by the cancer cell and triggers its death. Aside from metastatic solid tumors, the partners are also advancing BNT324 for prostate cancer, for which they received the FDA’s Fast Track designation in June 2024.
The BMO analysts called BNT324’s efficacy profile “encouraging” and its safety findings “competitive,” raising the potential for combination regimens with immuno-oncology agents.
Merus Targets Second-Line Head and Neck Cancer with Anti-EGFR/LGR5 Antibody
Merus will present Phase II data on Saturday for petosemtamab, which it is positioning as a treatment option for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Results from the mid-stage readout showed a 40.4% overall response rate among the 47 evaluable patients, including 19 patients who achieved partial response. Median duration of response was 7.2 months, while median progression-free survival reached 5.1 months. Median overall survival was 12.5 months.
As for safety, the most common treatment-emergent toxicities included infusion-related reactions (IRR), acneiform dermatitis and lowered blood magnesium levels. Five patients dropped out of the study due to IRRs.
These data come from Merus’ abstract, also shared by BMO Capital Markets in an investor note last week. According to the firm’s analysts, the ESMO Asia readout “further increases our confidence in a positive outcome in the Phase 3 … trial evaluating peto in 2L+ HNSCC versus cetuximab.”
“The data update reinforces our view on peto’s clinical profile in head and neck cancers and should dispel bear arguments ahead of this data disclosure,” the analysts added.
Petosemtamab is a full-length IgG1 antibody that targets both EGFR and LGR5. According to Merus, this binding profile gives petosemtamab three independent mechanisms of action, including the inhibition of EGFR signaling, blocking of LGR5 signaling and promotion of antibody-dependent anticancer activity.
AstraZeneca, Daiichi Sankyo Present Consolidated NSCLC Data for Dato-DXd
AstraZeneca and Daiichi Sankyo will unveil consolidated lung cancer data Friday for their ADC datopotamab deruxtecan (Dato-DXd).
The presentation will focus on a pooled analysis of the Phase III TROPION-Lung01 and TROPION-Lung05 studies in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC), though the abstract for the talk has yet to be made widely accessible.
Last month, AstraZeneca and Daiichi Sankyo announced that they had submitted a Biologics License Application (BLA) for Dato-DXd in this indication, backing it with data from both TROPION-Lung01 and TROPION-Lung05. The partners in February 2025 filed a separate BLA for Dato-DXd focusing on a non-squamous NSCLC patient population, for which the FDA’s verdict is due on Dec. 20.
Dato-DXd’s results in NSCLC are mixed, however. In September 2024, the partners announced that the ADC failed to significantly improve overall survival in the TROPION-Lung01 trial. Compared with docetaxel chemotherapy, Dato-DXd reduced the risk of death by 6%, an effect that fell short of statistical significance. Even in the non-squamous patient subgroup, where the overall survival benefit hit 16%, Dato-DXd was likewise unable to demonstrate statistically significant improvements.
In a note to investors last week, Jefferies analysts wrote that the ESMO Asia 2024 presentation could give investors “an opportunity to assess for themselves whether FDA seems likely to approve Dato for NSCLC,” which in turn has the potential to positively affect share prices of AstraZeneca and Daiichi Sankyo.
