Monthly oncology bulletin — September 28, 2026

Period covered: August 29 to September 28, 2026. The month was dominated by the World Conference on Lung Cancer (WCLC 2026, Seoul, September 12–15), the International Myeloma Society meeting (IMS 2026, Glasgow, September 23–26), the CSCO annual meeting (Jinan, September 17–19), and a wave of regulatory decisions from the FDA, EMA, PMDA, and ANVISA. Sixteen items, each verified against its source. Several congress results do not yet have a peer-reviewed publication; this is flagged item by item.

1. Common solid tumors

1. Camizestrant + CDK4/6 inhibitor upon detection of ESR1 mutation in blood (SERENA-6)

[Regulatory FDA] [USA]
On September 4, the FDA granted accelerated approval to camizestrant (Etcamah, AstraZeneca) with a CDK4/6 inhibitor for HR+/HER2− advanced breast cancer when an ESR1 mutation is detected in circulating tumor DNA during first-line aromatase inhibitor + CDK4/6 inhibitor therapy. In SERENA-6 (double-blind, n=315), switching to camizestrant versus continuing the aromatase inhibitor improved median PFS from 9.2 to 16 months (HR 0.44; 95% CI 0.31–0.60). Overall survival is immature; Guardant360 CDx was approved as the companion diagnostic.
Why it matters: it introduces liquid-biopsy–guided switching before radiographic progression, but requires serial ctDNA monitoring (more than 3,200 patients screened), an advisory committee voted against approval, and no survival benefit has been shown yet; in the Dominican Republic, access to the test is the main barrier.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative
https://www.ajmc.com/view/5-notable-fda-approvals-from-the-first-half-of-september

2. Imlunestrant + abemaciclib in ER+/HER2− ESR1-mutated breast cancer (EMBER-3)

[Regulatory FDA] [USA]
On September 18, the FDA approved imlunestrant (Inluriyo) with abemaciclib (Lilly) for ER+/HER2− advanced breast cancer with an ESR1 mutation after at least one line of endocrine therapy. In the ESR1-mutated subgroup of EMBER-3 (n=159 of 874), the combination versus imlunestrant alone achieved median PFS of 11.1 versus 5.5 months (HR 0.53; 95% CI 0.35–0.80) and response rates of 35% versus 15%.
Why it matters: the FDA labels the subgroup exploratory, and imlunestrant alone did not beat endocrine therapy in the overall population; this is another oral option after progression, not a new standard, and it relies on the same ctDNA test.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or

3. Brazil approves first-line sacituzumab govitecan for triple-negative breast cancer

[Regulatory ANVISA] [Brazil]
On September 8, ANVISA registered two new first-line indications for sacituzumab govitecan (Trodelvy) in unresectable or metastatic triple-negative breast cancer: with pembrolizumab for PD-L1–expressing tumors, and as monotherapy for patients who are not candidates for PD-1/PD-L1 inhibitors. (source in Portuguese)
Why it matters: ANVISA is the first reference agency in Latin America to add these indications and often precedes other regulators in the region; cost remains the main barrier for public health systems.
https://www.dgabc.com.br/Noticia/4346135/anvisa-aprova-novas-indicacoes-para-remedio-que-trata-cancer-de-mama

4. Zanidatamab + tislelizumab + chemotherapy in HER2+ gastric cancer (HERIZON-GEA-01)

[Regulatory FDA] [USA]
On August 25, the FDA approved zanidatamab (Ziihera), a bispecific anti-HER2 antibody, with tislelizumab and chemotherapy for first-line HER2+ (IHC 3+ or 2+/ISH+) gastric, gastroesophageal junction, or esophageal adenocarcinoma. Compared with trastuzumab + chemotherapy, the triplet increased median OS from 19.2 to 26.4 months (HR 0.72; 95% CI 0.57–0.90) and PFS from 8.1 to 12.4 months (HR 0.63).
Why it matters: this is the largest survival gain in HER2+ gastric cancer since ToGA and will likely displace trastuzumab; the trial was open-label and industry-sponsored, and the approval falls 34 days before this issue's cutoff but is included because of its weight.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction

5. ADAURA at 8 years: adjuvant osimertinib maintains its survival advantage

[Congress] [International · WCLC Seoul]
In the 8-year ADAURA update (n=682, resected EGFR-mutated stage IB–IIIA NSCLC), 8-year OS in stage II–IIIA was 74% with osimertinib versus 58% with placebo (HR 0.53; 95% CI 0.38–0.75); in the overall population, 79% versus 64% (HR 0.52). Published simultaneously in the Journal of Thoracic Oncology.
Why it matters: this is an exploratory analysis of an already positive trial, but it consolidates adjuvant osimertinib and makes EGFR testing mandatory in every resected NSCLC, which is not yet universal in the region.
https://www.oncologynewscentral.com/nsclc/osimertinib-maintains-8-year-overall-survival-in-egfr-lung-cancer
https://www.jto.org/article/S1556-0864(26)00632-5/fulltext

2. Immunotherapy, antibody–drug conjugates, and targeted therapy

6. DESTINY-Lung04: first-line trastuzumab deruxtecan in HER2-mutant lung cancer

[Congress] [International · WCLC Seoul]
Phase 3 trial (n=454) in untreated nonsquamous NSCLC with HER2 mutations (exon 19/20): T-DXd versus pembrolizumab + platinum + pemetrexed. Median PFS 14.3 versus 8.3 months (HR 0.63; 95% CI 0.50–0.79) and response rates of 70% versus 44.5%. Interim OS numerically favored the control arm (29.3 versus 33.1 months; HR 1.15), with adjudicated pneumonitis in 20.8% versus 2.3%.
Why it matters: a clear PFS benefit, but the unfavorable interim OS (attributed to imbalanced subsequent therapies) and pneumonitis preclude calling it a new standard until mature data are available; no simultaneous publication.
https://www.iaslc.org/iaslc-news/press-release/phase-3-destiny-lung04-trial-shows-first-line-trastuzumab-deruxtecan

7. REZILIENT3: zipalertinib + chemotherapy in EGFR exon 20 insertion NSCLC

[Congress] [International · WCLC Seoul]
Open-label phase 3 trial (n=279) in first-line NSCLC with EGFR exon 20 insertions: zipalertinib + platinum-pemetrexed versus chemotherapy alone. Median PFS by blinded central review 14.5 versus 8.5 months (HR 0.50; 95% CI 0.34–0.73), response rates 65% versus 40%; interim OS immature (HR 0.72; CI 0.42–1.23). Grade ≥3 adverse events: 87.1% versus 54.4%.
Why it matters: it joins other positive first-line options in this population, with considerable toxicity; the choice will depend on toxicity profile, oral administration, and access.
https://www.iaslc.org/iaslc-news/press-release/zipalertinib-plus-chemotherapy-significantly-extends-progression-free

8. DeLLphi-305: tarlatamab + durvalumab improves survival in extensive-stage small cell lung cancer

[Industry] [USA]
On September 8, Amgen announced that adding tarlatamab (a DLL3×CD3 bispecific) to durvalumab maintenance after chemoimmunotherapy induction significantly prolonged OS, as well as PFS and response rate, in 563 patients with extensive-stage SCLC at a prespecified interim analysis. No figures have been disclosed.
Why it matters: it would be the first bispecific with an OS benefit in first-line SCLC, but without medians or an HR it is a press release, not evaluable data; figures are expected at an upcoming congress.
https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer

9. Daraxonrasib, the first approved pan-RAS inhibitor: previously treated metastatic pancreatic cancer (RASolute 302)

[Regulatory FDA] [USA]
On August 26, the FDA approved daraxonrasib (Rasonque, Revolution Medicines) for metastatic pancreatic adenocarcinoma after at least one prior line or in patients who are not candidates for multiagent chemotherapy. In RASolute 302 (n=500, versus physician's choice of chemotherapy), median OS was 13.2 versus 6.7 months (HR 0.40; 95% CI 0.30–0.53), PFS 7.2 versus 3.6 months, and response rate 30% versus 11%.
Why it matters: doubling survival in second-line pancreatic cancer is unprecedented; the trial was open-label and sponsor-run, and approval came six and a half months ahead of its goal date; the CSCO guideline already includes it (item 15). Included because of its weight, although it falls 33 days before the cutoff.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma

10. Izalontamab brengitecan (EGFR×HER3 bispecific ADC) in pretreated triple-negative breast cancer

[Congress] [China]
At CSCO 2026 (Jinan), data for iza-bren (BL-B01D1, Biokin) were reviewed. In PANKU-Breast02 (phase 3, n=418, metastatic TNBC after 1–2 prior lines) versus physician's choice of chemotherapy, median PFS by central review was 8.5 versus 3.1 months (71% risk reduction), and OS 15.9 versus 12.5 months. NMPA approved it in July for esophageal squamous cell carcinoma. (source in Chinese)
Why it matters: a striking magnitude, but this was a company symposium without a formal HR or peer-reviewed publication, in an exclusively Chinese population; the global IZABRIGHT-Breast01 trial will show whether it replicates.
https://www.sohu.com/a/1079548964_122014422

11. Japan: PMDA approves more than ten oncology indications at once

[Regulatory PMDA] [Japan]
On September 16, Japan approved, among others: subcutaneous pembrolizumab (with berahyaluronidase alfa) for all its indications; tovorafenib for BRAF-altered low-grade glioma; mirvetuximab soravtansine for FRα+ platinum-resistant ovarian cancer; dordaviprone for diffuse midline glioma; datopotamab deruxtecan for HR−/HER2− breast cancer; teclistamab for relapsed/refractory myeloma; and subcutaneous amivantamab for EGFR-mutated NSCLC. (source in Japanese)
Why it matters: it confirms Japan's regulatory convergence with the FDA/EMA, and subcutaneous pembrolizumab and amivantamab may reduce chair time, an efficiency argument for our services too.
https://www.pmda.go.jp/files/000281577.pdf

12. EMA (CHMP, September 14–17): perioperative enfortumab + pembrolizumab without cisplatin restriction

[Regulatory EMA] [European Union]
The CHMP recommended extending neoadjuvant and adjuvant enfortumab vedotin + pembrolizumab in resectable muscle-invasive bladder cancer to cisplatin-eligible patients; it also recommended ensartinib (ALK+ NSCLC), relacorilant with nab-paclitaxel (platinum-resistant ovarian cancer), senaparib (ovarian cancer maintenance), and extending teclistamab to myeloma after a single prior line.
Why it matters: the bladder change turns a platinum-free regimen into a perioperative option for all patients; CHMP opinions still require a European Commission decision.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026

3. Hematologic malignancies

13. IMS 2026: minimal residual disease at the center (CEPHEUS and DREAMM-8)

[Congress] [International · Glasgow]
In CEPHEUS (n=395, newly diagnosed myeloma, transplant-ineligible or transplant-deferred), with 76 months of follow-up, DVRd versus VRd achieved MRD negativity (10⁻⁵) in 61.4% versus 39.9% and PFS HR 0.59 (95% CI 0.44–0.80). In DREAMM-8 (belantamab + pomalidomide-dexamethasone versus bortezomib-pomalidomide-dexamethasone), sustained MRD negativity was 15.5% versus 2.7%.
Why it matters: it reinforces anti-CD38 quadruplets in transplant-ineligible patients and MRD as an endpoint; these are congress updates, and in the Dominican Republic daratumumab and belantamab remain of limited access.
https://www.targetedonc.com/view/ims-2026-day-4-mrd-guided-regimens-real-world-car-t-data

14. Ropeginterferon alfa-2b approved for essential thrombocythemia (SURPASS ET)

[Regulatory FDA] [USA]
On September 1, the FDA approved ropeginterferon alfa-2b (Besremi) for adults with essential thrombocythemia. In SURPASS ET (n=174, resistant or intolerant to hydroxyurea), durable modified ELN response at months 9 and 12 was 37.4% versus 3.6% with anagrelide. Japan approved it for the same indication on August 24.
Why it matters: the first approved disease-modifying alternative after hydroxyurea, useful in younger patients; the source is secondary and does not report thrombotic outcomes.
https://www.ajmc.com/view/5-notable-fda-approvals-from-the-first-half-of-september

4. Screening, prevention, supportive care, radiotherapy, surgery, and access

15. CSCO 2026 pancreatic cancer guideline: mandatory KRAS testing and tumor treating fields at level I

[Guideline] [China]
The guideline presented at the CSCO meeting (September 17–19) makes KRAS testing mandatory, upgrades tumor treating fields (TTFields) with chemotherapy to level I in locally advanced disease (PANOVA-3: OS 16.2 versus 14.2 months; HR 0.82), raises NALIRIFOX to level I in first-line metastatic disease, moves minimally invasive pancreatoduodenectomy to level II, and adds RAS inhibitors. (source in Chinese)
Why it matters: it shows how quickly Asian guidelines integrate new data; the TTFields benefit is modest and costly, and systematic KRAS testing is the recommendation most transferable to our setting.
https://www.sohu.com/a/1081188195_121118854

Screening, prevention, palliative care, and radiotherapy: no new verifiable trial or guideline with practical impact was found this month.

Cross-cutting

16. AI: a "virtual laboratory" of agents proposes a lung cancer drug

[Publication] [USA]
Nature (September 17) reports on work published in Science in which a system of up to 37,000 AI agents, coordinated by a "chief scientist" agent, identified a therapeutic candidate for lung cancer.
Why it matters: this is a preclinical proof of concept with no patient data; it is interesting as a signal of where drug discovery is heading, not as clinical news.
https://www.nature.com/articles/d41586-026-02954-y

Regional coverage: Russia registered neoadjuvant camrelizumab for triple-negative breast cancer, but on August 19 (outside the period). No verifiable data were found this month from the Dominican Republic, Mexico, Colombia, Argentina, India, Korea (beyond WCLC), Turkey, or the Middle East.

Upcoming meetings and dates

• ESMO Congress 2026: Madrid, October 23–27. DeLLphi-305 figures are expected.
• Anito-cel (anti-BCMA CAR-T): FDA decision date December 23, 2026 (beyond the 6-week window, worth watching).

Monthly oncology bulletin — September 28, 2026

16 verified items, sourced from FDA, EMA, PMDA, ANVISA, IASLC (WCLC 2026), IMS 2026, CSCO, and the Journal of Thoracic Oncology.

Three worth your time:
• Daraxonrasib, the first approved pan-RAS inhibitor (FDA): in previously treated metastatic pancreatic cancer, OS 13.2 vs 6.7 months (HR 0.40). Open-label, sponsor-run trial.
• DESTINY-Lung04: first-line T-DXd in HER2-mutant NSCLC, PFS 14.3 vs 8.3 months (HR 0.63), but interim OS HR 1.15 and 20.8% pneumonitis.
• Zanidatamab + tislelizumab + chemotherapy in HER2+ gastric cancer: OS 26.4 vs 19.2 months (HR 0.72). Cost will limit access in low- and middle-income settings.

Full bulletin, with a critical appraisal of every study and links to primary sources:
https://boletinesmedicos.com/en/oncologia/2026-09-28.html

#Oncology #Cancer #LungCancer #WCLC2026 #PancreaticCancer

Oncology, Sept 2026: daraxonrasib doubles OS in pretreated pancreatic cancer (13.2 vs 6.7 mo; HR 0.40). DESTINY-Lung04: T-DXd improves PFS in HER2-mutant NSCLC (HR 0.63), but interim OS not yet favorable. https://boletinesmedicos.com/en/oncologia/2026-09-28.html