- AstraZeneca (AZ) will most likely have to rein in its hopes of gaining accelerated approval for durvalumab, which is being developed for treatment of lung cancer. Results from the ADVANCE clinical trial don’t appear strong enough to support fast-tracking.
- In a statement released Friday, AZ’s Chief Medical officer, Sean Bohen, said, “We now believe it is unlikely ATLANTIC can be used for regulatory submission as a monotherapy.” However, he suggested it could be a candidate for combo therapy.
- AZ needed a stronger outcome with the ADVANCE trial. However, Bohen has assured investors that AZ is still on track to gain eventual approval for durvalumab.
Although AZ is attempting to assure investors durvalumab is still a top contender in the race for part of the lung cancer market, the competitive landscape continues to shift—and not in AZ's favor.
Merck's Keytruda and Bristol-Meyers Squibb's Opdivo have already made significant inroads into the lung cancer market and provide a strong PD-L1 therapeutic option. In addition, Roche's atezolizumab has quickly gained traction as a strong candidate for a lung cancer indication.
Nonetheless, opportunities remain in the immune-oncology space. AZ can pursue additional indications for durvalumab as it marches towards its 2023 revenue goals. The development program for durvalumab spans multiple tumor types, and stages of disease, examining the therapeutic efficacy of the drug by itself or in combination with other medications.