On 30 May, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, AstraZeneca will release the first results from its first-in-human, modular, open-label Phase I/II trial, PRIMAVERA (NCT06137144). This introduces the first-in-class drug AZD3470, a selective PRMT5 inhibitor blocking arginine dimethylation for the treatment of haematological malignancies. Results will be presented from the arm for classic Hodgkin lymphoma (HL), a rare B-cell cancer with over 83,000 new diagnoses per year globally.
A key opinion leader (KOL) interviewed by GlobalData was strikingly enthusiastic about the early results: “Most first-in-humans, to be honest, don’t work that well, but this is actually working quite well….To get a drug like that is very exciting.”
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HL patients are typically managed with combinations of chemotherapy, radiotherapy, and targeted agents, including Adcetris (brentuximab vedotin), developed by Pfizer in the US and Takeda globally, Bristol Myers Squibb’s Opdivo (nivolumab), and MSD’s Keytruda (pembrolizumab). For first-line patients, current regimens are highly effective; the Opdivo with chemotherapy regimen boasts a three-year progression-free survival of 91% with favourable safety, according to the SWOG 1826 trial (NCT03907488). However, for 10%–30% of patients who are relapsed/refractory (r/r) after first-line therapy, treatment options quickly become exhausted. The main arm of PRIMAVERA focuses on a high-risk population of r/r patients who have failed after at least two prior lines of therapy, including at least two cycles of Adcetris and anti-PD1.
The KOL emphasised: “When patients have failed everything, to get a decent response to a drug is quite unusual.” Encouragingly, AZD3470 seems comparable to Adcetris and Opdivo in this setting, which may promise a third class of therapy that could lead to a cure where all else has failed.
However, even with encouraging efficacy data, penetrating the HL market is challenging. The KOL explains: “The problem is the bar is so high, because we cure so many patients, it’s quite hard to do.” Indeed, no new first-in-class drug has successfully entered the US HL market since the 2016 arrival of Opdivo as the first anti-PD-1 immunotherapy. GlobalData’s patient-based sales forecast for 2025 shows that the $2.4bn US market is dominated entirely by Adcetris, Opdivo, and Keytruda. A new drug focused primarily on patients who are r/r following these drugs will only treat a very rare disease group, so AstraZeneca will likely need to integrate AZD3470 earlier within the treatment paradigm for it to be commercially viable.
The PRIMAVERA trial has two other arms that explore this. One investigates AZD3470 as consolidation in older patients after first-line therapy, looking to reduce r/r incidence altogether and create a niche where no options currently exist. The other investigates AZD3470 combined with Keytruda for r/r patients, potentially offering a chemotherapy-free alternative to the Keytruda + chemotherapy regimen, currently widely deployed. However, upcoming results will be reporting on the first dose-escalation phase, so it will be some time before data from these other arms, as well as crucial data on the durability of responses, emerge. Overall, there is a clear intent from AstraZeneca to introduce AZD3470 to this stagnant market, and ASCO will provide the first formal glimpse of how achievable that ambition is.
