On October 18 I wrote that ESMO could show how good intismeran, the personalized mRNA cancer vaccine Moderna makes with Merck, is in melanoma, but not whether Moderna has a cancer platform. The data leaked on October 22 and the stock fell 17.6%. My read now is that the melanoma result was good, the drop fairly took out some melanoma hype, and the price still pays for a second cancer that hasn't been tested.
The data leaked online through an erroneous posting on the morning of October 22, and Merck put out the full INTerpath-001 results that afternoon, two days before the ESMO presentation (BioSpace). The trial gave 1,137 melanoma patients, after surgery, either intismeran plus KEYTRUDA, Merck's standard immunotherapy, or KEYTRUDA alone. The hazard ratio for recurrence was 0.58, which means about 42% fewer recurrences or deaths than KEYTRUDA alone. At two years, 82.2% on the combination were recurrence-free, against 70.0%. Survival data aren't mature yet.
The scorecard
What I said I'd check, and what came out
| What I said I'd check | What came out | My read |
|---|---|---|
| RFS hazard ratio against the Phase 2b's 0.51 | 0.58 (95% CI 0.45 to 0.75), against KEYTRUDA alone | Weaker, though the Phase 2b's own range ran from 0.29 to 0.89 |
| Against the 0.57 and 0.65 behind the KEYTRUDA and Opdivo approvals after surgery | Those were against placebo and against Yervoy; this one is against KEYTRUDA | Similar size against a tougher comparator |
| Whether any overall-survival data are shown | Not mature; a favorable trend, no hazard ratio | The open question for a filing |
| Any randomized result outside melanoma | None; three lung Phase 3 trials ongoing, plus a Phase 1 pancreatic study and a gastric study | The platform question is untouched |
Against the bar I wrote down, the headline came in weaker. RBC called 0.58 the low end of what investors had hoped for, and that's roughly what the stock traded on.
I think the comparison that matters is a different one. When KEYTRUDA was approved after melanoma surgery in 2019, its hazard ratio was 0.57, and that was against placebo. Intismeran's 0.58 is against KEYTRUDA. They're different trials with different patients, so it's rough, but adding a drug to an approved one and getting about the same cut in recurrences that the approved drug got against nothing is a strong result. I'd still treat a melanoma filing as likely.
| Period | RFS hazard ratio |
|---|---|
| Phase 2b, 5 years | 0.51 |
| Phase 3, all | 0.58 |
| Phase 3, months 0 to 6 | 0.99 |
| Phase 3, after month 6 | 0.42 |
The part I didn't expect is the timing. Over the first six months the two arms looked the same. After the vaccine course was finished, the combination pulled well ahead. That's the shape you'd expect if the immune response the doses build is doing the work. Merck also reported a modified analysis that came in at 0.51, the same as the Phase 2b. Both are cuts the companies chose to show, so I wouldn't lean on them too hard, but neither points the wrong way.
Grading myself
Where I was right and where I wasn't
I got the narrow point right. The data sized the melanoma product and said nothing about a second cancer, because no randomized trial outside melanoma has read out. The test I set in the original, a randomized win outside melanoma by the end of 2027, is exactly where it was.
| Period | MRNA close |
|---|---|
| Aug 18 | $63 |
| Aug 19 | $174 |
| Oct 14 | $226 |
| Oct 15 | $237 |
| Oct 16 | $218 |
| Oct 19 | $227 |
| Oct 20 | $242 |
| Oct 21 | $246 |
| Oct 22 | $203 |
| Oct 23 | $200 |
I got the price wrong going in. I expected the data to be the test. Instead the stock ran 12.8% into it and then gave all of that back in one day. A drop that size on a melanoma number tells me a lot of the late buying was a bet on a huge melanoma result. I gave that possibility one paragraph in October and said I couldn't rule it out. It deserved more weight.
What's left is the question I care about. The stock page kept its bull, base and bear values after the data, because its base case already assumed a melanoma result like this one. At the October 23 close Moderna still sat above that base, so it's still paying for part of a second cancer before any randomized data exists. The scorecard has the live numbers, next to Regeneron and Vertex from the original's comparison.
| Name | |||||
|---|---|---|---|---|---|
| Cancer therapy not yet approved | |||||
| MRNAModerna | 65 | 73 | 55 | 62 | |
| Approvals rivals can't match | |||||
| REGNRegeneron | 76 | 68 | 71 | 72 | |
| VRTXVertex Pharmaceuticals | 70 | 74 | 66 | 70 | |
The counter-case
The case that the selloff was right, or not big enough
The strongest argument against me is that the melanoma product is smaller than even 0.58 suggests. BMO called Bristol Myers' NADINA trial of Opdivo plus Yervoy a compelling standard for the disease, with an event-free survival hazard ratio of 0.32, though it said the two can't be compared directly (BioSpace). BMO expects doctors to choose case by case, since there's no head-to-head data. To be fair to the drug, BMO also noted serious treatment-related side effects of 10% here against 30% in NADINA, and sees intismeran as the pick for patients who can't take two checkpoint drugs.
Overall survival is the other gap. Merck says only that there's a favorable trend and that the companies are engaging with regulators, with no filing date. KEYTRUDA and Opdivo were both approved after surgery on recurrence-free survival, so I think a filing can go in without it, but I can't show that FDA will agree. Side effects also ran higher than on KEYTRUDA alone, with fever in about half the patients, though severe ones were close at 14.2% against 13.4%.
If a split market and a wait for survival data make melanoma slower than the stock at $245.81 assumed, the market was right to reprice it, and I think it mostly was. That doesn't touch the platform question. It just means the melanoma premium is gone and the second-cancer premium is still there.
Next
What I'm checking next
| When | What | What it tells me |
|---|---|---|
| Nov 6, 2026 | Third-quarter results | Cash after the $2.6 billion convertible priced in August |
| Nov 12, 2026 | Analyst Day | Timing for the kidney and bladder Phase 2 readouts, and any filing date |
| Next 14 months | More than three potentially registrational datasets, including kidney, bladder and lung | The first randomized test outside melanoma |
The first randomized readout outside melanoma is the real test, and I'll come back to it then.
Next read
Moderna Stock Before ESMO 2026: The Data Can Prove a Melanoma Drug, the Price Assumes a Platform
Moderna had more than tripled from its pre-readout close by October 16, and its October 24 ESMO data can show how good a melanoma drug intismeran is, but I think the price is paying for an mRNA cancer platform that only a randomized win in a second tumor type can prove.
Keep readingWhat would prove this wrong
HoldingBy December 31, 2027, neither Merck nor Moderna has announced that FDA accepted a filing for intismeran in resected melanoma, or either discloses that FDA asked for mature overall survival first. Either would mean the 0.58 result against KEYTRUDA was weaker for approval than this note argues.
Sources
- [1]Merck and Moderna Will Present Results From Landmark Phase 3 INTerpath-001 Trial for Intismeran Autogene Plus KEYTRUDA (pembrolizumab) at ESMO 2026 Presidential Symposium — Merck, October 22, 2026 · Press release
- [2]Moderna (MRNA) Stock Price History — Stock Analysis, October 26, 2026 · Third party
- [3]ESMO 2026: Merck, Moderna shares fall as cancer vaccine disappoints after data leak — BioSpace, October 22, 2026 · Third party
- [4]ESMO 2026: Analysts warm to Merck, Moderna's cancer vaccine after frustrating data leak — BioSpace, October 26, 2026 · Third party
- [5]Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Melanoma at 2026 ASCO — Moderna, June 1, 2026 · Press release
- [6]Chart of the Day: Moderna's 177% Day — The Trading Tools, August 19, 2026 · Third party
- [7]Moderna Reports Second Quarter 2026 Financial Results (Form 8-K, Exhibit 99.1) — Moderna via SEC EDGAR, July 31, 2026 · Filing
- [8]FDA approves pembrolizumab for adjuvant treatment of melanoma — U.S. Food and Drug Administration, February 15, 2019 · Regulator
- [9]FDA grants regular approval to nivolumab for adjuvant treatment of melanoma — ESMO, December 20, 2017 · Third party
- [10]Moderna to Report Third Quarter 2026 Financial Results on Friday, November 6, 2026 — Moderna, October 13, 2026 · Press release
- [11]Moderna Announces Pricing of Upsized $2.6 Billion Offering of Convertible Senior Notes — Moderna, August 28, 2026 · Press release
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