Roche turns up the heat on Lilly with another Gavreto approval, elbowing its way into the thyroid cancer space
Roche and Blueprint Medicines are continuing to put pressure on rivals Eli Lilly and Loxo, as their Gavreto drug picked up a new approval Wednesday.
The companies announced that the FDA has given the thumbs-up for Gavreto to treat RET-mutation and RET-fusion positive thyroid cancers, less than three months after the drug received its first approval in non-small cell lung cancer with RET fusions. Gavreto is now set to fully compete with Lilly’s Retevmo after the latter’s brief period as the only developer with an OK’ed medicine for this specific gene alteration.
Though Roche and Blueprint finished second to Lilly in this race, it was only by a couple of months. Retevmo picked up its approvals all at once back in May and is still in the early stages of rollout, netting roughly $12 million for Lilly in the third quarter this year.
Gavreto’s new accelerated approval comes from a Phase I/II study that showed an overall response rate of 60% in 55 RET-mutant patients with previous treatments, and an ORR of 66% in 29 RET-mutant patients who were treatment-naïve. Additionally, 8 of 9 individuals with RET-fusion positive tumors demonstrated a clinical response to the drug.
In all three patient populations, the median duration of response was not reached. Across all tumor types, the most common side effects were constipation, hypertension, fatigue, muscle pain and diarrhea.
Wednesday’s approval should service a much larger swathe of thyroid cancer patients than in NSCLC, as about 10 to 20% of people with papillary thyroid cancer have RET fusion-positive tumors and roughly 90% of people with advanced MTC (a rare form of thyroid cancer) carry RET mutations. That contrasts with RET fusions making up only about 1% to 2% of NSCLC patients.
Analysts now view this race as neck and neck, with Wedbush’s David Nierengarten saying Gavreto should split the RET-altered thyroid cancer market 50/50 with Retevmo. Cowen’s Marc Frahm expects a slightly smaller market share for Gavreto at 35%, noting that the drug’s 9% discontinuation rate in thyroid cancer remained higher than Retevmo’s 5%.
Nonetheless, Frahm projects peak Gavreto sales to hit about $550 million per year.
Both pharma companies have pinned high expectations for their respective drugs. Roche plunked down $775 million upfront for the rights in July — $675 million of which was in cash — and promised Blueprint as much as $927 million in milestone payments, in addition to royalties on sales outside the US. Lilly, meanwhile, bought out Loxo entirely for a 68% premium price of $8 billion in early 2019.