Last updated: September 14, 2026
AstraZeneca said September 12 that SERENA-4, the 1,371 patient first line trial of Etcamah (camizestrant) plus palbociclib, missed its primary progression free survival endpoint, eight days after the FDA approved the drug on the SERENA-6 ctDNA switch strategy. The approved indication is unaffected.
This page covers the SERENA-4 miss and what it means for the Etcamah franchise, the weekend’s WCLC 2026 data in Seoul including ARTEMIS-008 and REZILIENT3, SK Biopharmaceuticals’ timeline for the Biohaven opakalim hold, the Exelixis review extension, two resolved open items, and the week’s catalyst calendar.
What happened in AstraZeneca’s SERENA-4 trial?
SERENA-4 tested camizestrant plus palbociclib against anastrozole plus palbociclib in 1,371 patients with ER positive, HER2 negative advanced breast cancer who had received no prior systemic therapy for advanced disease. The trial missed its primary endpoint of investigator assessed progression free survival, AstraZeneca said in a September 12 press release.
The company reported a numerical progression free survival advantage for the camizestrant arm that did not reach statistical significance. No hazard ratio and no median figures have been disclosed. Susan Galbraith, who runs oncology research and development at AstraZeneca, said the outcome “sharpens our focus on maximising the number of patients who can benefit from Etcamah today.” The result was reported the same day by STAT and Fierce Pharma.
How can a drug fail first line eight days after a first line approval?
Because the two trials define first line differently. The FDA’s September 4 accelerated approval rests on SERENA-6, which enrolled patients already on a first line aromatase inhibitor plus CDK4/6 inhibitor whose circulating tumor DNA showed an emergent ESR1 mutation before imaging showed progression. Switching those patients to camizestrant extended median progression free survival to 16.8 months versus 9.2 months for staying the course. SERENA-4 asked the harder, conventional question: give camizestrant to everyone from day one instead of an aromatase inhibitor. That answer came back negative.
| Trial | Design | Population | Result | Status |
|---|---|---|---|---|
| SERENA-6 | ctDNA guided switch at ESR1 mutation emergence | On first line therapy, ESR1 mutation emergent | Median PFS 16.8 vs 9.2 months | Basis of the September 4 accelerated approval |
| SERENA-4 | Upfront camizestrant plus palbociclib vs anastrozole plus palbociclib | Untreated advanced disease, 1,371 patients | Missed primary PFS endpoint; numerical advantage only | Announced September 12; no figures disclosed |
The approved indication is unaffected, and AstraZeneca’s remaining path to a broad early use of the drug now runs through the CAMBRIA-1 and CAMBRIA-2 adjuvant trials, a program of roughly 10,000 patients in early stage disease. SERENA-4 is also the third first line miss for the oral SERD class in a row: Roche’s giredestrant fell short in persevERA on a numerical improvement that did not reach significance, and Fierce Pharma notes the readacross now hangs over Olema’s first line program.
What did WCLC 2026 deliver over the weekend?
The IASLC World Conference on Lung Cancer opened September 12 in Seoul and runs through September 15, with 1,677 abstracts. Two Presidential Symposium readouts produced hard numbers over the weekend, and one long awaited dataset has still not shown its figures.
| Readout | Drug and sponsor | Setting | Headline result | Source status |
|---|---|---|---|---|
| ARTEMIS-008 | Risvutatug rezetecan (HS-20093), Hansoh; GSK holds rights outside Greater China | Relapsed small cell lung cancer vs topotecan | Median OS 18.5 vs 10.3 months, HR 0.46 | Company release, September 13 |
| REZILIENT3 | Zipalertinib, Cullinan and Taiho | First line EGFR exon 20 insertion NSCLC, plus chemotherapy | Median PFS 14.5 vs 8.5 months, HR 0.50 | Company release, September 13 |
| DESTINY-Lung04 | Trastuzumab deruxtecan, AstraZeneca and Daiichi Sankyo | First line HER2 mutant NSCLC vs chemoimmunotherapy | Met primary endpoint on blinded independent review PFS; figures per congress coverage | Congress coverage |
| DeLLphi-305 | Tarlatamab plus durvalumab, Amgen and AstraZeneca | First line maintenance in extensive stage SCLC | Overall survival win announced September 8; numbers still withheld | Listed in WCLC program per congress coverage; no figures as of September 13 night |
How big is the ARTEMIS-008 survival benefit in small cell lung cancer?
Risvutatug rezetecan cut the risk of death by 54 percent versus topotecan in relapsed small cell lung cancer, with median overall survival of 18.5 months versus 10.3 months. Hansoh presented the interim analysis as a late breaker in the WCLC Presidential Symposium on September 13.
The trial randomized 461 patients in China whose disease had progressed after platinum based therapy. At a June 6, 2026 data cutoff with 12.2 months median follow up, the B7-H3 directed antibody drug conjugate posted a hazard ratio of 0.46 (95 percent CI 0.35 to 0.62), a 12 month overall survival rate of 64.5 percent versus 43.3 percent, median progression free survival of 7.2 versus 3.0 months, and a 58.3 percent response rate versus 12.6 percent for topotecan. Grade 3 or higher treatment related adverse events were lower on the ADC arm, 60.9 percent versus 78.2 percent, and the fatal hematologic events in the trial occurred only on topotecan. Hansoh says China’s NMPA accepted the drug’s application on September 2 with priority review. GSK, which paid $185 million upfront in 2023 for rights outside Greater China per BioPharma Dive, is running a global Phase 3 with results expected in 2027. A second B7-H3 ADC, in the TAISHAN-302 trial, also reported a positive readout against topotecan at the meeting per congress coverage.
Two cautions apply. The data are interim, from a single country trial, and cross trial comparison in relapsed SCLC is treacherous. And the readacross question that followed ivonescimab’s China first data into its global program applies here in full: the number that matters for GSK is the 2027 global readout.
What did zipalertinib show in first line exon 20 lung cancer?
Zipalertinib plus chemotherapy extended median progression free survival to 14.5 months versus 8.5 months for chemotherapy alone in first line EGFR exon 20 insertion NSCLC, a six month gain with a hazard ratio of 0.50 (95 percent CI 0.34 to 0.73, p=0.00015), per the Cullinan and Taiho release.
REZILIENT3 randomized 279 patients, about 31 percent of them with brain metastases at baseline. Response rate was 65.0 percent versus 40.3 percent, median duration of response 14.2 versus 9.9 months. Interim overall survival, at 30 percent maturity, showed a hazard ratio of 0.72 with a confidence interval crossing one; follow up continues. Grade 3 or higher adverse events were more common with the combination, 87.1 percent versus 54.4 percent, driven by hematologic toxicity. The data were presented in the Presidential Symposium on September 14 in Seoul. For Cullinan, the readout lands five months ahead of the February 27, 2027 FDA decision on zipalertinib in the second line setting, and it makes the first line program the asset’s real value case.
What is SK Biopharmaceuticals’ timeline for the Biohaven opakalim hold?
SK Biopharmaceuticals expects the FDA’s partial clinical hold on opakalim to be resolved between October and November, and said it will not pay the deal’s upfront or close the Kv7 license until it is. Yoo Chang-ho, SK’s head of strategy, laid out the timeline at a September 11 briefing reported by the Seoul Economic Daily.
Per SK, Biohaven will submit the requested nonclinical metabolite data to the FDA between late September and early October. The partial hold, disclosed September 10, pauses new enrollment in the focal epilepsy program over a metabolite finding in rodent studies while the more than 600 patients already enrolled continue dosing. RISE 3, fully enrolled since June, remains on track for topline results in the second half of 2026 per both companies; RISE 2 recruitment stays paused. The gating matters because the up to $795 million license, with $350 million due at closing under the announced terms, was signed before the hold surfaced, and SK says the cash now waits on the FDA. SK reviewed the full data package including the metabolite before signing, per prior analyst commentary reported by BioPharma Dive.
Why did the FDA push the Exelixis zanzalintinib decision to March?
The FDA extended its review of zanzalintinib plus atezolizumab in metastatic colorectal cancer by three months, moving the action date from December 3, 2026 to March 3, 2027, after Exelixis submitted updated safety and efficacy data in response to an agency information request, per reporting from Reuters, Endpoints News, and Benzinga. The submission was classified a major amendment. The agency identified no specific new concern in the reporting, and Exelixis shares closed Friday at $56.12, down 2.3 percent on the session.
The extension extends a pattern. Capricor’s deramiocel moved to November 22 on a major amendment. Summit’s ivonescimab decision on November 14 carries flagged extension risk. Scholar Rock’s September 30 apitegromab date and Ultragenyx’s September 19 UX111 date both sit in queue reviews. A three month slip is becoming the default cost of answering an FDA information request late in review, which is worth pricing into every fourth quarter action date on the calendar.
Which long running open items resolved this weekend?
Two. First, the Lilly purchase of Sangamo’s platform assets closed on September 4, per an 8-K Sangamo filed September 8. Lilly paid $50 million in cash for the STAC-BBB AAV capsid engineering platform, the zinc finger protein technology, the Modular Integrase genome editing platform, the ST-506 prion disease program, related intellectual property, and future milestone and royalty rights. The filing does not address PTC’s companion purchase from the $163.55 million auction, which remains unconfirmed. We had held this item at “report only after a primary confirms” since the September 4 expected close date passed; the filing is that primary.
Second, Axogen priced the offering funding its BioCircuit acquisition: 4,910,000 shares at $42.50 for gross proceeds of about $208.7 million, with a 736,500 share greenshoe, per the company’s September 10 release. The stock closed Friday at $42.16, just below the offer price. Substantially all net proceeds fund the $200 million cash portion of the BioCircuit deal, which is expected to close in the fourth quarter.
What is still unresolved going into the week of September 14?
As of our Sunday night check: Amylyx has still not announced the close of its $500.2 million offering, and Friday marked the tenth consecutive close below the $35.50 offer price, at $31.62. The underwriters’ greenshoe window forces disclosure by roughly September 18. The Amgen OCEAN(a) language test comes Tuesday at Morgan Stanley. DeLLphi-305 numbers had not been presented as of Sunday night. The Overton confirmation hearing remains unscheduled, no tenth MFN signatory has emerged, ADARx and Oura have not priced, Etcamah’s launch price remains unpublished, and Grail’s advisory committee briefing documents, expected around September 21, are not yet posted.
What is on this week’s catalyst calendar?
| Date | Event | Ticker |
|---|---|---|
| Sept 12 to 15 | WCLC 2026, Seoul; DeLLphi-305 full data window | AMGN / AZN / CGEM / GSK |
| Sept 15 | Amgen at Morgan Stanley healthcare conference, 11:30 am ET; the OCEAN(a) language test. Amylyx presents the same day | AMGN / AMLX |
| ~Sept 18 | Amylyx greenshoe window forces offering close disclosure | AMLX |
| Sept 19 | Ultragenyx UX111 PDUFA, Sanfilippo syndrome type A, queue review | RARE |
| ~Sept 21 | Grail Galleri advisory committee briefing documents expected | GRAL |
| Sept 23 | Grail Galleri FDA advisory committee, first MCED PMA panel | GRAL |
| Sept 25 | AbbVie full CERVINO etentamig data | ABBV |
| Sept 29 | Section 232 tariffs; Arbutus tender expires | Multiple / ABUS |
| Sept 30 | Scholar Rock apitegromab action date; GENEROUS Medicaid MFN opt in deadline | SRRK / Multiple |
Frequently asked questions
Did SERENA-4 failing change Etcamah’s FDA approval?
No. The September 4 accelerated approval covers a different population: patients on first line therapy whose ctDNA shows an emergent ESR1 mutation, based on SERENA-6. AstraZeneca confirmed the approved indication is unaffected by the SERENA-4 result.
What was the primary endpoint of SERENA-4?
Investigator assessed progression free survival. Camizestrant plus palbociclib showed a numerical advantage over anastrozole plus palbociclib that did not reach statistical significance, per AstraZeneca. Medians and hazard ratios have not been disclosed.
How many patients were in SERENA-4?
1,371 adults with ER positive, HER2 negative advanced breast cancer who had not received prior systemic therapy for advanced disease, per AstraZeneca’s release.
Has any oral SERD won a first line advanced breast cancer trial?
No. SERENA-4 is the third straight first line Phase 3 miss for the class, following Roche’s giredestrant in persevERA, which also showed a nonsignificant numerical improvement. Olema’s first line trial is still running.
What is risvutatug rezetecan?
A B7-H3 directed antibody drug conjugate, also coded HS-20093, developed by Hansoh Pharma. GSK licensed rights outside Greater China in 2023 for $185 million upfront. In the ARTEMIS-008 interim analysis it cut the risk of death by 54 percent versus topotecan in relapsed small cell lung cancer.
What were the exact ARTEMIS-008 numbers?
Median overall survival 18.5 versus 10.3 months, hazard ratio 0.46 (95 percent CI 0.35 to 0.62); 12 month survival 64.5 versus 43.3 percent; median PFS 7.2 versus 3.0 months; response rate 58.3 versus 12.6 percent, in 461 randomized patients in China, per Hansoh’s September 13 release.
When will GSK have global data for risvutatug rezetecan?
GSK’s global Phase 3 in extensive stage small cell lung cancer is expected to read out in 2027, per BioPharma Dive. ARTEMIS-008 was conducted entirely in China, so the global trial is the number that matters for Western markets.
What did zipalertinib show at WCLC 2026?
In REZILIENT3, zipalertinib plus chemotherapy delivered median progression free survival of 14.5 months versus 8.5 months for chemotherapy alone in first line EGFR exon 20 insertion NSCLC, hazard ratio 0.50, with a 65.0 percent response rate, per the Cullinan and Taiho release.
When will the FDA decide on zipalertinib?
The FDA’s decision on zipalertinib in previously treated exon 20 disease is due February 27, 2027. The REZILIENT3 first line data would support a later filing to move the drug earlier.
Have the DeLLphi-305 tarlatamab numbers been released?
Not as of the night of September 13. Amgen announced on September 8 that the trial met overall survival at an interim analysis but withheld the figures. The trial appears in WCLC 2026 congress coverage, and the meeting runs through September 15.
When will the Biohaven opakalim hold be resolved?
SK Biopharmaceuticals says Biohaven will submit the requested nonclinical data between late September and early October and expects resolution between October and November. The FDA, not the companies, controls the actual timing. RISE 3 topline results are still expected in the second half of 2026.
Is SK still paying Biohaven the upfront?
SK says the upfront has not been paid and the license will close only after the hold is resolved. The announced terms include $350 million due at closing out of a deal worth up to $795 million.
What did Lilly actually get from Sangamo?
For $50 million in cash: the STAC-BBB AAV capsid engineering platform, zinc finger protein technology, the Modular Integrase genome editing platform, the ST-506 preclinical prion disease program, related IP, and future milestone and royalty rights, per Sangamo’s 8-K. The purchase closed September 4.
What is the new zanzalintinib action date?
March 3, 2027, extended from December 3, 2026, after the FDA classified newly submitted safety and efficacy data as a major amendment, per Reuters and Endpoints News reporting. Exelixis said the agency raised no specific new concern in that reporting.
What happens at the Ultragenyx UX111 PDUFA on September 19?
The FDA is due to decide on UX111, an AAV gene therapy for Sanfilippo syndrome type A, on Friday under a review running through the agency’s backlogged queue. Ultragenyx has also signaled an expense reduction whose scope it has not detailed, making Friday a forced disclosure moment on two fronts.
Sources
Primary sources: AstraZeneca press release on SERENA-4, September 12, 2026. Hansoh Pharma press release on ARTEMIS-008, September 13, 2026. Cullinan Therapeutics and Taiho press release on REZILIENT3, September 13, 2026. Amgen press release on DeLLphi-305, September 8, 2026. Sangamo Therapeutics Form 8-K, filed September 8, 2026. Axogen pricing release, September 10, 2026. Robinhood exchange close data, September 11, 2026 session.
Trade and wire coverage (September 11 to 13, 2026): STAT News and Fierce Pharma on SERENA-4. Seoul Economic Daily on SK Biopharmaceuticals’ opakalim briefing. Reuters, Endpoints News, Benzinga, and Investing.com on the Exelixis extension. Fierce Biotech on the GSK B7-H3 ADC and the De Claro interview. BioSpace on Samsung Biologics, Disc Medicine, and Novartis governance. OncoDaily WCLC 2026 congress coverage. BioPharma Dive on the GSK and Hansoh license terms. Endpoints News on Takeda and Novo Nordisk leadership. MedTech Dive and STAT on the AI EKG clearance.
Related coverage
Read our Friday briefing on the Biohaven partial hold, the Artisan Partners demand at Novartis, and the surrogate discount week tally, our coverage of the Etcamah approval on the SERENA-6 ctDNA resistance signal, our report on the arlo-cel pivotal win with the numbers withheld, and our binary ledger reference table.
