What Lifecycle Management Lessons Can We Learn From Pd-1 Immuno-Oncology Therapies?

To understand the early lifecycle management strategies of innovative oncology immunotherapies, specifically the PD-1 drugs pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb), for application across disease areas. Targeted secondary research using combinations of key words (‘PD-1’, ‘Keytruda’, ‘Opdivo’, ‘FDA’, ‘Pembrolizumab’, ‘Nivolumab’, ‘Approval’, ‘Immuno-oncology’) identified source literature, which was abstracted and analyzed qualitatively. Key themes were discussed in a consensus meeting and implications of findings were theorized. Several lifecycle management strategies were identified from secondary research, including: indication expansion, patient segmentation using biomarkers, and combining with other drug treatments. Pembrolizumab and nivolumab - both holders of Breakthrough Therapy status - received accelerated approval from the FDA for advanced melanoma in late 2014. Nivolumab subsequently received approval for NSCLC in March 2015, while pembrolizumab was under FDA Priority Review for the same indication as of June 2015. Nivolumab is also under Priority Review in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) for melanoma. Both PD-1 therapies are in numerous clinical trials for further oncology indications, and pembrolizumab has shown improved response rates in patients with a specific genetic biomarker, which is predictive of response across a range of cancers. In highly competitive therapeutic areas, manufacturers of innovative products need to consider multiple strategies for creating, maintaining, protecting and increasing product value. Demonstration of substantial improvements in clinical efficacy over the standard of care in one indication is not sufficient for ‘success’. Earlier access through the FDA’s Breakthrough Therapy designation and accelerated approval program is critical for first-to-market entrants. Expansion into both larger and more niche indications offers a complementary access strategy, while gaining a foothold in combination regimens provides opportunity for further product differentiation. Similar considerations apply to therapies that can treat several indications within a broader disease area.