Amgen (AMGN) put numbers on its biggest lung cancer win yet on Saturday, Oct. 24. In the Phase 3 DeLLphi-305 trial, Imdelltra added to Imfinzi from AstraZeneca (AZN) cut the risk of death by 58% versus Imfinzi alone, as a first-line maintenance treatment for extensive-stage small-cell lung cancer (SCLC).
Amgen said on Sept. 8 that the trial had met its survival goal, but it held the figures for this weekend’s ESMO Congress, where they ran in the Presidential Symposium and in The New England Journal of Medicine. The stock hasn’t traded on them yet. Shares head into Monday near the record $447.28 close from Oct. 22, up more than a third this year.
The Numbers Behind the Hype
- Median overall survival: 21.1 months, versus 12.7 months on Imfinzi alone
- Alive at one year: nearly 80%, versus 53%
- Median progression-free survival: 7.4 months, versus 1.9 months
- Response rate: 26.4%, versus 4.1%
This is an interim read at about 16 months of median follow-up. Side effects rose too: grade 3 or higher treatment-related events hit 20.9% of patients on the combination, against 10.8% on Imfinzi alone. About half had cytokine release syndrome, almost all of it mild (one grade 3 case).
Chief Medical Officer Paul Burton called it “a true watershed moment” for the disease in an interview with Fierce Pharma. He also sized the prize: Imdelltra’s current label covers about 13,000 U.S. patients, and that could reach 35,000 to 40,000 if Amgen’s other earlier-line trials succeed too.
Imdelltra Is Still Small Next to Amgen
Imdelltra sales more than tripled from about $80 million in Q1 2025 to $260 million in Q1 2026, and Q2 sales jumped 115% to $288 million. That’s a real launch. It’s also about 2.9% of the $10.05 billion Amgen booked in the quarter.
In the same quarter, Prolia and Xgeva fell from a combined $1.65 billion to $1.11 billion as biosimilars moved in. That $540 million drop is nearly twice Imdelltra’s entire quarter.
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Is the Ramp Already in the Forecast?
Analysts expect Amgen’s revenue to climb from $38.97 billion in 2026 to $45.19 billion in 2030, about 4% a year, or roughly $1.5 billion of new sales annually.
At its Q2 pace, Imdelltra runs at about $1.15 billion a year, around 3% of this year’s estimate. Even if first-line use doubled that, the extra sales would amount to less than one year of the growth the Street already models. Great data for the drug doesn’t automatically mean a bigger number for the company.
How Much of This Is Priced In
The multiple says investors got there early. Amgen trades at 18.62x forward normalized earnings, close to its one-year high of 18.96x and well above its 16.18x average. From the 14.11x low, the multiple has climbed about 32%.
Part of that re-rating was earned: Amgen beat in Q2 and lifted its 2026 revenue guidance to $38.2 billion to $39.4 billion. But it means DeLLphi-305 lands on a stock already priced for good news.
Who Else Feels It
- AstraZeneca: Maintenance runs until the cancer progresses, so a regimen that holds it off for 7.4 months instead of 1.9 keeps patients on Imfinzi far longer. AstraZeneca also helped fund the trial.
- Jazz Pharmaceuticals (JAZZ): Its Zepzelca plus Tecentriq from Roche (RHHBY) won approval in the same setting on 13.2 months of median survival, versus 10.6 months. Imdelltra just set a much higher bar.
- Zai Lab (ZLAB): Its DLL3 drug zoci goes after the same target, though it’s also in an Amgen-sponsored combination study.
What DeLLphi-305 Changes for Amgen Stock
For SCLC patients, this is the best survival data in years. For Amgen shareholders, it strengthens a growth driver without changing the size of the company: Imdelltra is about 3% of sales, and the stock already sits near its richest multiple of the past year. I’d treat the result as support for today’s price, not a reason to chase it.
The next check comes on Nov. 3, when third-quarter results show whether Imdelltra clears $300 million in a quarter and whether Amgen puts a date on its filings.
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