AstraZeneca’s run of optimistic trial outcomes with its most cancers therapies has continued with a win for its immunotherapy Imfinzi in non-muscle invasive bladder most cancers (NMIBC).
High-line outcomes from the POTOMAC trial revealed this morning present that one yr of remedy with PD-L1 inhibitor Imfinzi (durvalumab) plus customary BCG induction and upkeep remedy achieved a “statistically important and clinically significant enchancment in disease-free survival (DFS)” in comparison with customary remedy alone.
A second arm of the research evaluating Imfinzi plus BCG induction-only remedy to BCG induction and upkeep remedy alone didn’t attain statistical significance for DFS.
The brand new knowledge comes shortly after Imfinzi was accepted as a peri-operative remedy for muscle-invasive bladder most cancers (MIBC), primarily based on the outcomes of the NIAGARA trial, which marked a return to the bladder most cancers space.
The drug claimed accelerated approval in beforehand handled grownup sufferers with regionally superior or metastatic types of the illness in 2017, though that was subsequently withdrawn after the failure of a confirmatory research.
The brand new NMIBC indication, which is being ready for submitting, represents a “significant new alternative” for Imfinzi, which introduced in round $4.7 billion in gross sales for AZ final yr from its present labelling throughout lung, liver, endometrial, biliary tract, and bladder cancers, in line with current feedback by AZ’s head of oncology R&D, Susan Galbraith.
That stated, there was a string of current approvals in NMIBC which have made the phase extra aggressive, together with for MSD’s rival PD-1 inhibitor Keytruda (pembrolizumab), ImmunityBio’s Anktiva, and Ferring’s Adstiladrin, whereas Johnson & Johnson is anticipating a verdict from the US FDA later this yr for its TAR-200 candidate.
Greater than 70% of bladder most cancers sufferers are recognized with NMIBC, an early-stage most cancers the place the tumour is within the tissue that strains the internal floor of the bladder however has not invaded the muscle wall, in line with AZ. Amongst these, round half will probably be at excessive danger of development to extra critical illness.
POTOMAC’s lead investigator, Maria De Santis of Charité Universitätsmedizin Berlin in Germany, stated that the DFS outcomes are “thrilling” as a result of “whereas most sufferers with [NMIBC] are handled with healing intent, 80% see their illness return and virtually half could require life-altering surgical procedure to take away the bladder.”
Imfinzi is being examined in a spread of research throughout early and late-stage bladder most cancers in varied remedy mixtures, together with the VOLGA research in sufferers with MIBC who’re ineligible or refuse to take cisplatin and the NILE research as a first-line remedy versus chemotherapy in regionally superior or metastatic illness.
The brand new outcome follows arduous on the heels of optimistic knowledge with Daiichi Sankyo-partnered Enhertu (trastuzumab deruxtecan) in early-stage and superior types of breast most cancers.
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