iTeos Therapeutics has announced that it has “deprioritised” inupadenant for the treatment of non-small cell lung cancer (NSCLC), following disappointing mid-stage data. Instead, the company will focus on other programmes, including its TIGIT therapies.
The Phase II A2A-005 trial considered the use of inupadenant – an adenosine A2A antagonist – plus platinum-doublet chemotherapy in post-immunotherapy metastatic NSCLC.
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The topline data presented at the ESMO Immuno-Oncology Congress in Geneva, Switzerland, yesterday (12 December) considered 36 patients eligible for safety and efficacy evaluation at the cutoff date (29 October). Patients had received inupadenant at 40mg, 60mg or 80mg twice-daily in combination with pemetrexed and carboplatin.
The data demonstrated that inupadenant in combination with pemetrexed and carboplatin did meet the primary safety and tolerability endpoints, with no dose-dependent toxicities.
However, the secondary endpoints, while met, were disappointing. iTeos reported that inupadenant in combination with pemetrexed and carboplatin demonstrated an objective response rate (ORR) of 63.9% across all patients (53.3% at 40mg, 66.7% at 60mg, and 73.3% at 80mg).
The results suggest that, compared to other (cheaper) treatments, there is little additional benefit to inupadenant. The standard-of-care first-line treatment for most patients with advanced NSCLC after immunotherapy is platinum-based doublet therapy. A study published in 2018 showed an increase in classical responses to chemotherapy after treatment with PD-1/PD-L1 inhibitors and demonstrated that this saw an average ORR of 66.7% – similar to the Phase II A2A-005 results.
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By GlobalDataAnother secondary endpoint was months of progression-free survival. The results were 5.6 months for the 40mg dose and 6.6 months at 60mg. The 80mg group had not reached the point of progression at the cutoff point.
Of the results, iTeos president and CEO Michel Detheux said: “While the initial signal for inupadenant’s RP2D in the A2A-005 trial compared to chemotherapy alone is encouraging and supports its differentiated, insurmountable profile, we as well as our scientific and clinical advisory boards believe it does not meet sufficient level of clinical activity to warrant further investment.
“We remain committed to focusing our resources on developing differentiated, first- or best-in-class therapies and look forward to providing updates on our pipeline in 2025.”
iTeos’pipeline currently includes three clinical-stage programmes targeting novel, validated immunosuppressive pathways. These include its Phase III trial of its TIGIT antibody belrestotug (EOS-448), which it is developing and marketing for the treatment of NSCLC in collaboration with GSK.
The companies shared the results of the Phase II TIGIT trial in September, which demonstrated more than 30% difference in confirmed overall response rates between the investigational treatment versus monotherapy. Results of the Phase III trial are highly anticipated.
