Bayer’s radioligand therapy (RLT), Xofigo (radium-223 dichloride), has demonstrated its first-line, combinatory treatment potential in metastatic castration resistant prostate cancer (mCRPC) with bone metastases in a pivotal Phase III trial.
During the open-label, investigator-initiated PEACE-3 study (NCT02194842), a combination of Xofigo and Pfizer and Astellas Pharma’s Xtandi (enzalutamide) reduced the risk of death by 24% compared with Xtandi alone.
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The combination also offered a significant overall survival (OS) benefit, with patients randomised to receive Xofigo-Xtandi experiencing a median OS of 38.2 months. This represents a 5.6-month increase over the 32.6-month median OS observed in the Xtandi monotherapy group. This result comes as global regulators increasingly require sponsors to demonstrate a drug’s OS benefit – reaffirming its role as the gold standard endpoint for cancer trials.
The final OS figures follow on from the positive outcomes of a primary analysis on the PEACE-3 study, which revealed that a combination of Xofigo and Xtandi significantly improved radiological progression-free survival (rPFS) to 19.4 months versus the 16.4-month rPFS observed in the Xtandi-only cohort – meeting the trial’s primary endpoint.
While the treatment combination demonstrated efficacy, it did trigger an increase in serious treatment-emergent adverse events (TEAEs), with 69% of patients experiencing events classed as Grade 3 or higher compared with 58% in the Xtandi monotherapy arm. However, no individual severe TEAE increased by more than 5% in patients given the combination compared with Xtandi alone.
This trial was sponsored by the European Organisation for Research and Treatment of Cancer (EORTC), a non-profit that aims to conduct international translational and clinical research to drive informed clinical decision-making.
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By GlobalDataRLTs gain traction in oncology
As cancer treatments continue to improve, several new and advanced modalities have emerged as disruptors in the oncology treatment paradigm, which once revolved heavily around chemotherapy.
One of these drug classes is the radiopharmaceuticals, which have seen successful incorporation into the prostate cancer treatment paradigm through the US approvals of Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in prostate-specific membrane antigen (PSMA)-positive mCRPC and Xofigo as a monotherapy in mCRPC with bone metastases.
GlobalData, the parent company of Clinical Trials Arena, predicts that this modality within prostate cancer alone will generate $6.3bn in sales in 2030 – an increase primarily driven by ballooning Pluvicto profits.
As the uptake of RLTs increase within oncology, pharma companies are looking to grab a slice of the market, with big players like AstraZeneca, Eli Lilly and Bristol Myers Squibb (BMS) all inking multi-billion dollar M&A deals with radiopharmaceutical-focused companies between 2023 and 2024.
It appears that investors are also taking an increased interest in the RLT modality, as venture financing reached a record high of $408m in 2023, while undergoing a 330% surge in Q1 2024 compared with the same period in 2023.
In conversation with Pharmaceutical Technology, sister publication to Clinical Trials Arena, experts noted that theranostics could represent the future of the radiopharmaceutical field, as the combination of diagnostic and therapeutic molecules could facilitate precise and image-driven treatment in oncology.
