Imdelltra plus Imfinzi cut first line small cell lung cancer death risk 58% at ESMO on October 24, 2026, with median survival of 21.1 versus 12.7 months.
Last updated: October 26, 2026
Amgen’s tarlatamab added to durvalumab maintenance reduced the risk of death 58% in first line extensive stage small cell lung cancer, with median overall survival of 21.1 months versus 12.7 months. The Phase 3 DeLLphi-305 results were presented at ESMO and published in the New England Journal of Medicine.
This page covers the ESMO Congress 2026 weekend data in full, the Moderna and Merck melanoma vaccine results, the week’s diagnostics deals, and the IPO window, with primary sources throughout.
What did the DeLLphi-305 trial show in small cell lung cancer?
DeLLphi-305 showed that adding Imdelltra (tarlatamab) to Imfinzi (durvalumab) maintenance after first line chemoimmunotherapy cut the risk of death 58% versus durvalumab alone in extensive stage small cell lung cancer. Median overall survival reached 21.1 months, against 12.7 months for the control arm.
The global Phase 3 study randomized 563 patients who had not progressed after initial platinum chemotherapy, etoposide and durvalumab, including patients with treated and untreated asymptomatic brain metastases. Amgen announced the results on Saturday morning, October 24, around the ESMO Presidential Symposium presentation, with simultaneous publication in the New England Journal of Medicine; AstraZeneca, which markets durvalumab, issued a parallel release the same morning.
| Endpoint | Tarlatamab + durvalumab | Durvalumab alone |
|---|---|---|
| Median overall survival | 21.1 months | 12.7 months |
| Hazard ratio for death | 0.42 (95% CI 0.32 to 0.54, p<0.001) | |
| One year survival | About 80% (74.2 to 83.7) | 53% (47.3 to 59.0) |
| Median progression free survival | 7.4 months | 1.9 months |
| Hazard ratio for progression or death | 0.34 (95% CI 0.28 to 0.42, p<0.001) | |
| Objective response rate | 26.4% | 4.1% |
| Grade 3 or higher treatment related adverse events | 20.9% | 10.8% |
Cytokine release syndrome occurred in 49.6% of tarlatamab patients, almost all grade 1 or 2 (grade 3 in 0.4%, none higher). Immune effector cell associated neurotoxicity syndrome occurred in 1.1% of patients with no grade 3 or higher events. Amgen’s development chief Jay Bradner called the results an unprecedented advance for the disease.
How big is the change to the small cell lung cancer standard of care?
Small cell lung cancer survival benchmarks have barely moved in decades, and a doubling of the one year survival gap in the maintenance setting is the kind of result that redraws treatment guidelines rather than refining them. The same release carried supporting evidence from two other trials.
DeLLphi-303, the Phase 1b study of the same combination, now shows median overall survival of 37.9 months measured from the start of first line maintenance, with 58.1% of patients alive at two years. DeLLphi-304, the Phase 3 trial in second line disease that supported Imdelltra’s existing position, shows median survival of 13.6 versus 8.4 months against chemotherapy at 23 months of follow up.
Two practical notes for operators. First, cytokine release syndrome management differs by geography: United States labeling practice in the trial allowed one to two hours of monitoring after the first cycle infusions, while certain regions including Europe used six to eight hours, a real difference in infusion chair economics. Second, the win is shared: AstraZeneca co announced the data because durvalumab is the backbone, so the trial simultaneously strengthens Imfinzi’s first line franchise and makes Amgen’s bispecific its new dependency. Boehringer Ingelheim, meanwhile, used the same congress to build the case for its rival DLL3 bispecific, per Fierce Biotech.
Saturday’s release means Monday, October 26 is the first trading session in which the market can react. Amgen closed Friday at 439.26, down 1.8%, and AstraZeneca at 171.49, down 0.6%, both before the data crossed.
Did Roche’s divarasib beat sotorasib and adagrasib head to head?
Yes. In Krascendo 1, the first head to head Phase 3 inside the KRAS G12C inhibitor class, divarasib extended median overall survival to 17.7 months versus 12.0 months for a pooled control of the two approved drugs, sotorasib and adagrasib, in previously treated KRAS G12C mutated non small cell lung cancer.
| Endpoint | Divarasib | Sotorasib or adagrasib |
|---|---|---|
| Median overall survival | 17.7 months | 12.0 months |
| Hazard ratio for death | 0.56 (95% CI 0.41 to 0.78, p=0.0005) | |
| Median progression free survival | 9.8 months | 5.7 months |
| Confirmed objective response rate | 58% | 32% |
| Median duration of response | 11.9 months | 6.9 months |
| Serious treatment related adverse events | 7.8% | 15.2% |
The study enrolled 338 patients and read out at ESMO’s Presidential Symposium on Sunday with simultaneous New England Journal of Medicine publication. Lead author Ferdinandos Skoulidis called divarasib the first KRAS inhibitor to meaningfully improve overall survival. Roche says it is working with health authorities; no submission date was given. First line (Krascendo 2, with pembrolizumab) and adjuvant (Krascendo 3) Phase 3 trials are running. Eli Lilly, racing from behind, presented durable first line activity data for its own KRAS G12C inhibitor olomorasib on Sunday. Monday is the first reaction session; Roche’s United States listing closed Friday at 61.17 (an ADR).
Why did Moderna’s stock fall if the melanoma vaccine trial succeeded?
Because the win was priced for more. INTerpath-001, the Phase 3 trial of intismeran autogene plus Keytruda in resected stage IIB to IV melanoma, met both endpoints, but the 42% reduction in recurrence or death risk landed at the bottom of the 40% to 50% range analysts had expected, and below the 49% seen in the Phase 2 study at five years. Moderna shares, which had roughly quadrupled since August’s topline announcement, fell 17.6% on Thursday, October 22, the day screenshots of the data leaked on social media, and slipped another 1.2% Friday to close at 200.10. Merck fell 1.8% and 1.3% the same two sessions.
The detailed figures, reported by BioPharma Dive and Fierce Biotech from the ESMO presentation, show recurrence free survival of 82.2% versus 70% at 24 months (hazard ratio 0.58) and distant metastasis free survival of 88.5% versus 80.2% (hazard ratio 0.62, a 38% reduction). The 1,137 patient trial randomized two to one against Keytruda alone. Safety was similar overall with more fever and injection site pain in the vaccine arm, and 7% versus 5% discontinuation. The leak forced ESMO to release the findings two days before the planned Saturday Presidential Symposium presentation; Merck’s clinical development head called it unfortunate and said nothing in the presentation was rewritten. Merck is preparing a United States filing and hopes for an approval next year, per Fierce Biotech. Moderna had previously said a 35% risk reduction would be clinically significant, and investigators argued no prior trial had improved on PD-1 inhibition in this setting at all.
What did ivonescimab show in biliary tract cancer?
Akeso’s HARMONi-GI1 trial showed ivonescimab plus chemotherapy beat durvalumab plus chemotherapy on overall survival in first line advanced biliary tract cancer: median 14.9 versus 12.1 months, hazard ratio 0.75, at a planned interim analysis. It is the first Phase 3 in the disease to beat an approved immunotherapy regimen rather than chemotherapy alone.
The 682 patient, double blinded trial was run entirely in China by Akeso, which generated and analyzed the data; partner Summit Therapeutics announced the results Sunday alongside the ESMO Presidential Symposium presentation. Progression free survival was 8.4 versus 5.8 months (hazard ratio 0.61) and response rate 53.8% versus 32.5%. Serious adverse event rates were essentially identical between arms. Summit and ECOG-ACRIN announced a United States registration enabling study, EA2251, on October 21, with site activation expected to begin this quarter. The FDA decision on ivonescimab in lung cancer remains scheduled for November 14, and Monday is the first session for the market to weigh a second positive Phase 3 indication.
What happened in prostate cancer at ESMO?
Johnson & Johnson delivered the weekend’s most discussed early asset: JNJ-6143, the first molecule from its RIPTAC platform to enter the clinic, produced confirmed responses in 12 of 16 patients with measurable disease (75%) at the 50 mg dose in heavily pretreated metastatic castration resistant prostate cancer.
The caveats matter: the full 50 mg cohort held 38 patients with a median of four prior therapies, the response figure covers only those with measurable disease, and median follow up was 5.6 months. PSA fell at least 50% in 77% of the cohort and at least 90% in 48%. The oral molecule ties BRD4 to the androgen receptor so that the cancer’s own abundance of receptor becomes the killing mechanism. A Phase 2 study is next. Separately, J&J reported that perioperative Erleada cut recurrence or death risk 62% in high risk localized disease, and Bayer reported that Nubeqa plus hormone therapy and radiation cut metastasis or death risk 58% in high risk patients, each per the companies’ releases. Prostate cancer, long a backwater for practice changing data, produced three wins in one weekend.
What did Zentalis present for azenosertib in ovarian cancer?
Zentalis delivered the response detail its October 18 survival release had omitted. In the DENALI Part 1b rapid oral on Friday, azenosertib showed a 37.2% confirmed response rate with 5.5 months median duration of response in Cyclin E1 positive platinum resistant ovarian cancer, per Fierce Biotech’s conference reporting and interviews with management.
The survival figures from the company’s release stand: median overall survival of 15.8 months in Cyclin E1 positive patients versus 7.5 months in negative patients, an interim, retrospective and secondary endpoint analysis with overlapping confidence intervals. Zentalis executives told Fierce the response rate more than triples the 4% to 12% seen with single agent chemotherapy, and said precommercial planning has begun, with the accelerated approval cohort reading out in the first half of 2027 and the Phase 3 ASPENOVA trial enrolling toward 420 patients. The market read the duration number harshly: Zentalis closed Friday at 2.21, down 8.3% on the session after the presentation.
What happened in diagnostics last week?
Labcorp bought again, Quest got breached, and Edwards opened a new valve market. The diagnostics sector packed a quarter’s worth of structural news into the week ESMO started, and most of it crossed midweek while attention was on Madrid.
Labcorp agreed on Tuesday to buy Myriad Genetics’ prenatal testing business for $210 million, per MedTech Dive: the FirstGene, Prequel, Foresight and SneakPeek tests, with about $160 million in expected first year revenue. Evercore pegs the price at 1.3 times first year revenue, versus 2.9 times for the BioReference assets Labcorp agreed to buy the week before for up to $872 million. Myriad’s prenatal sales had fallen 16% year over year in the first half, and Labcorp also announced an abuse potential research collaboration with Charles River and the FDA on Thursday. Quest Diagnostics told the SEC on Wednesday that an unauthorized party accessed patient records through its Quanum Lab Services Manager system; the scope is undetermined and Quest says core operations are unaffected. It joins Stryker, Boston Scientific, Medtronic, Abbott and Intuitive on 2026’s medtech breach list, with Boston Scientific due to quantify its own attack on Wednesday’s earnings call. Edwards Lifesciences won FDA approval for the Pascal Precision system in tricuspid regurgitation, announced Wednesday per MedTech Dive, making Edwards the only United States provider of both transcatheter repair and replacement for the tricuspid valve. QIAGEN, a week into its agreed take private, closed Friday at 50.39, pinned to the EQT offer.
How did the biotech IPO window trade?
Lycia Therapeutics produced the strongest debut of the 2026 cohort. The extracellular protein degradation company sold 17,640,000 shares at $18.00 for $317.52 million gross on Thursday, upsized, and closed its first Nasdaq session Friday at 30.00, 66.7% above the offer (our arithmetic from the prospectus price and the settled close).
| Company | Offer | Friday close | Versus offer |
|---|---|---|---|
| Lycia (LYCA), debut Oct 23 | $18.00 | 30.00 | +66.7% |
| City Therapeutics (CTY) | $18.00 | 20.77 | +15.4% |
| Retension (RTSN) | $12.00 | 15.25 | +27.1% |
| Iambic (IAM) | $16.00 | 14.26 | −10.9% |
| Arcus follow on (RCUS) | $17.50 | 18.54 | +5.9% |
All percentages are our arithmetic from settled closes. Lycia, whose two clinical programs both read out in 2027, carries the least data in the cohort and commands the largest premium, while Iambic, the AI drug discovery listing with a dataset marking catalyst ahead, sits 10.9% below its offer. Elsewhere in the capital cycle: Zai Lab’s $250 million private placement was endorsed by its first reaction session, with the stock closing Friday at 24.03, 9.0% above the $22.04 placement price, ahead of an on or about October 27 close. Bolt Biotherapeutics struck a stock for stock reverse merger with Prana Therapies alongside a $120 million private placement, expandable to $180 million with warrants, per Fierce Biotech; Prana’s lead asset is a bispecific against IL-4Rα and TSLP in Phase 2 for asthma, COPD and atopic dermatitis. Star Therapeutics added $200 million, per BioPharma Dive.
Which stocks moved on Friday?
Friday, October 23 settled closes, with the story behind each move. Percentages are our arithmetic from exchange settled closes.
| Ticker | Friday close | Move | Why it matters |
|---|---|---|---|
| MRNA | 200.10 | −1.2% (after −17.6% Thursday) | Melanoma vaccine data leaked Thursday; a positive trial priced for more |
| LYCA | 30.00 | +66.7% versus $18.00 offer | Strongest debut of the 2026 IPO cohort, on the least clinical data |
| ZLAB | 24.03 | +9.0% | First session after the $250M placement; closed above the placement price |
| ZNTL | 2.21 | −8.3% | Session after the DENALI oral put a 5.5 month duration beside the response rate |
| MLYS | 20.55 | −4.3% | First reaction to ASN kidney data and a now dated December 22 PDUFA |
Context: XBI closed at 149.54, down 1.4%; SPY at 759.97, down 0.5%. The weekend’s ESMO tape (Amgen, AstraZeneca, Roche, Summit, Merck) meets its first trading session Monday.
Frequently asked questions
What is tarlatamab and how does it work?
Tarlatamab (Imdelltra) is Amgen’s bispecific T cell engager that links DLL3 on small cell lung cancer cells to CD3 on T cells, directing the immune system against the tumor. It was already approved in second line disease; DeLLphi-305 tested it as first line maintenance.
What survival benefit did Imdelltra plus Imfinzi show in DeLLphi-305?
Median overall survival of 21.1 months versus 12.7 months for durvalumab alone, a 58% reduction in the risk of death (hazard ratio 0.42), with about 80% of patients alive at one year versus 53%.
Is the DeLLphi-305 combination approved?
No. The data were presented October 24, 2026 at ESMO and published in the New England Journal of Medicine. Amgen has not announced a filing date for the first line maintenance indication.
How common was cytokine release syndrome with tarlatamab in DeLLphi-305?
49.6% of patients, but almost entirely mild: 41.8% grade 1 and 7.4% grade 2, with 0.4% grade 3 and nothing higher. Neurotoxicity (ICANS) occurred in 1.1% with no grade 3 or higher events.
What is divarasib and how did it compare with sotorasib and adagrasib?
Divarasib is Roche’s KRAS G12C inhibitor. In the Krascendo 1 Phase 3, it beat a pooled control of the two approved drugs head to head in previously treated lung cancer: median survival 17.7 versus 12.0 months and response rate 58% versus 32%, with fewer serious side effects.
What does the divarasib result mean for Amgen’s Lumakras and Bristol Myers Squibb’s Krazati?
A head to head overall survival loss inside the class is the hardest form of competitive evidence. If regulators approve divarasib on this data, the two incumbent KRAS G12C franchises face direct replacement pressure in second line lung cancer.
Did the Moderna Merck melanoma vaccine trial fail?
No. INTerpath-001 met both endpoints: a 42% reduction in recurrence or death risk and a 38% reduction in distant metastasis risk versus Keytruda alone. The stock fell because expectations, set by a 49% Phase 2 figure and an August topline announcement, were higher.
When could intismeran autogene be approved?
Merck says it is preparing a filing and hopes for a United States approval next year, per Fierce Biotech. Neither company has announced a submission date.
What is ivonescimab and why does the biliary tract cancer result matter?
Ivonescimab is Akeso’s PD-1 and VEGF bispecific, partnered with Summit Therapeutics outside China. HARMONi-GI1 is the first Phase 3 in biliary tract cancer to beat an approved immunotherapy regimen on overall survival, and it lands three weeks before the FDA’s November 14 decision on ivonescimab in lung cancer.
What is a RIPTAC and what did JNJ-6143 show?
A RIPTAC (regulated induced proximity targeting chimera) ties a protein a cancer cell needs to a protein the cancer overexpresses, turning abundance into a kill switch. JNJ-6143, the first in the clinic, produced confirmed responses in 12 of 16 measurable disease patients (75%) at 50 mg in heavily pretreated prostate cancer, in an early Phase 1 with 5.6 months median follow up.
What did Zentalis report for azenosertib at ESMO 2026?
A 37.2% confirmed response rate and 5.5 months median duration of response in Cyclin E1 positive platinum resistant ovarian cancer, per Fierce Biotech’s conference reporting, on top of the previously released 15.8 versus 7.5 month survival split by biomarker status.
What did Labcorp buy from Myriad Genetics?
Myriad’s prenatal testing business, including the FirstGene, Prequel, Foresight and SneakPeek tests, for $210 million, per MedTech Dive. Labcorp expects about $160 million in first year revenue. It follows the up to $872 million BioReference assets deal a week earlier.
What happened in the Quest Diagnostics cyberattack?
Quest disclosed to the SEC that an unauthorized party accessed patient records through its Quanum Lab Services Manager ordering and results system. The scope is still being determined; Quest says core operations are unaffected and law enforcement is engaged.
How did Lycia Therapeutics’ IPO price and trade?
Lycia sold 17,640,000 shares at $18.00 for $317.52 million gross, upsized, and closed its first session at 30.00 on Friday, October 23, 66.7% above the offer. Its LYTAC degraders pull disease proteins from outside cells into lysosomes; both clinical programs read out in 2027.
What should investors watch this week?
Monday’s first trading reaction to the ESMO weekend tape, Merck’s oncology investor event in Madrid on Monday afternoon, ESMO’s final sessions through Tuesday, Zai Lab’s placement close on or about October 27, Boston Scientific’s cyberattack quantification on Wednesday’s call, and the FDA’s Expedited IND pilot deadline Friday.
Sources
- Amgen press release, DeLLphi-305 Phase 3 results, October 24, 2026 (primary); AstraZeneca parallel release, October 24, 2026 (primary); New England Journal of Medicine simultaneous publication
- Roche press release, Krascendo 1 Phase 3 results, October 25, 2026 (primary); NEJM DOI 10.1056/NEJMoa2605703
- Summit Therapeutics press release, HARMONi-GI1 results, October 25, 2026 (primary); Akeso sponsored trial
- Johnson & Johnson press releases, JNJ-6143 Phase 1 and perioperative Erleada, October 24 to 25, 2026 (primary); Bayer press release, Nubeqa, October 24, 2026 (primary)
- AstraZeneca press release, CLARITY-Gastric01 sonesitatug vedotin, October 25, 2026 (primary)
- Zentalis press release, DENALI Part 1b overall survival, October 18, 2026 (primary); Fierce Biotech ESMO conference reporting and management interview, October 23, 2026 (attributed)
- BioPharma Dive, October 22, 2026 and Fierce Biotech, October 24, 2026: INTerpath-001 detailed figures from the ESMO presentation (attributed); Merck and Moderna August 19, 2026 joint topline release (primary for trial design)
- Lycia Therapeutics Form 424B4, October 22, 2026, sec.gov (primary)
- MedTech Dive, October 22 to 23, 2026: Labcorp and Myriad, Quest Diagnostics disclosure, Edwards Pascal Precision approval (attributed)
- Fierce Biotech, October 23, 2026: Bolt Biotherapeutics and Prana Therapies (attributed); BioPharma Dive: Star Therapeutics (attributed)
- All closing prices: exchange settled closes, October 22 to 23, 2026; percentage moves are our arithmetic
