Monthly oncology bulletin — October 4, 2026

Period covered: September 4 to October 4, 2026. The month was dominated by the IASLC World Conference on Lung Cancer (WCLC, Seoul), the International Myeloma Society annual meeting (IMS, Glasgow, September 23–26), and the ASTRO Annual Meeting (Boston, September 26–30). Fifteen verified items; six come from outside North America and Western Europe (China and Brazil). We found no verifiable data from this period from Japan, Korea, India, Russia, the Middle East, or the Dominican Republic.

1. Common solid tumors

1. ADAURA at 8 years: adjuvant osimertinib maintains its overall survival benefit

[Clinical trial] [International]
Eight-year update of the phase 3 ADAURA trial (n = 682; resected EGFR-mutant stage IB–IIIA NSCLC; osimertinib for 3 years vs placebo), presented at WCLC 2026 and published in the Journal of Thoracic Oncology. 8-year overall survival: 79% vs 64% in the overall population (HR 0.52; 95% CI 0.39–0.71) and 74% vs 58% in stage II–IIIA (HR 0.53).
Why it matters: it cements the standard and reinforces that every resected NSCLC should be tested for EGFR, which is still not routine in the Dominican Republic; the trial is sponsored by AstraZeneca.
https://ecancer.org/en/news/28876-wclc-2026-eight-year-adaura-update-shows-sustained-overall-survival-benefit-with-adjuvant-osimertinib-in-resected-egfr-mutated-nsclc

2. DESTINY-Lung04: first-line trastuzumab deruxtecan in HER2-mutant NSCLC

[Clinical trial] [International]
Phase 3 (n = 454, untreated advanced HER2-mutant NSCLC) vs pembrolizumab + platinum + pemetrexed, presented at WCLC 2026 (September 15). Median PFS 14.3 vs 8.3 months (HR 0.63; 95% CI 0.50–0.79); ORR 70.0% vs 44.5%. Overall survival does not favor the experimental arm (29.3 vs 33.1 months; HR 1.15), with imbalance in subsequent therapy; ILD/pneumonitis 20.8% vs 2.3%.
Why it matters: a clear PFS gain but no overall survival benefit and meaningful lung toxicity; first-line choice should be individualized. Sponsored by AstraZeneca/Daiichi Sankyo.
https://www.news-medical.net/news/20260915/T-DXd-significantly-extends-progression-free-survival-in-HER2-mutant-NSCLC.aspx
https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-in-DESTINY-Lung04-Phase-iii-trial.html

3. ER+/HER2– ESR1-mutant breast cancer: FDA approves camizestrant and imlunestrant; ANVISA approves camizestrant; SERENA-4 negative

[Regulatory FDA/ANVISA] [United States / Brazil]
On September 4 the FDA granted accelerated approval to camizestrant + a CDK4/6 inhibitor upon emergence of an ESR1 mutation in circulating tumor DNA during first-line therapy (SERENA-6, n = 315: PFS 16.8 vs 9.2 months; HR 0.45). On September 18 it approved imlunestrant + abemaciclib in ESR1-mutant advanced disease (EMBER-3, ESR1 subgroup: PFS 11.1 vs 5.5 months with imlunestrant alone). ANVISA approved camizestrant in Brazil on September 22. In contrast, SERENA-4 (n = 1,371, unselected first line, camizestrant + palbociclib vs anastrozole + palbociclib) did not reach significance for PFS (September 11).
Why it matters: the liquid-biopsy–guided switch strategy has not yet shown an overall survival benefit and requires serial ctDNA monitoring, which is scarcely available in the region; SERENA-4 confirms the benefit is confined to the ESR1-mutant population.
https://www.cancernetwork.com/view/fda-approves-camizestrant-for-esr1-mutated-hr-her2-advanced-breast-cancer
https://www.pharmacytimes.com/view/september-2026-in-oncology-5-updates-on-treatment-options-and-patient-care
https://www.jornaldocomercio.com/geral/2026/09/1264195-anvisa-aprova-novo-medicamento-oral-para-cancer-de-mama-avancado.html
https://www.cancernetwork.com/view/camizestrant-combo-misses-pfs-end-point-in-first-line-er-her2-breast-cancer
(ANVISA source in Portuguese)

4. Belzutifan + lenvatinib approved in clear cell renal cell carcinoma after immunotherapy

[Regulatory FDA] [United States]
September 24 approval based on LITESPARK-011 (n = 747; vs cabozantinib after anti–PD-1/PD-L1). Median PFS 14.6 vs 10.6 months; ORR 53% vs 40%; overall survival 33.7 vs 28.6 months, not statistically significant. Grade ≥3 toxicity in 71.6% (anemia, hypertension, diarrhea).
Why it matters: a new second-line option, but with high toxicity and no proven overall survival advantage over a cheaper, familiar cabozantinib.
https://www.onclive.com/view/fda-approves-belzutifan-plus-lenvatinib-for-advanced-ccrcc

2. Immunotherapy, antibody–drug conjugates and targeted therapy

5. HARMONi-2: ivonescimab beats pembrolizumab on overall survival in PD-L1–positive NSCLC

[Congress] [China]
Phase 3 (n = 398; first-line PD-L1–positive advanced NSCLC) of the PD-1/VEGF bispecific vs pembrolizumab, presented as a late-breaker at WCLC 2026. Median overall survival 30.8 vs 22.6 months (HR 0.73; 95% CI 0.57–0.95; p = 0.009); PFS 11.1 vs 5.8 months (HR 0.51). Serious adverse events 29.9% vs 21.6%.
Why it matters: the first agent to beat pembrolizumab on overall survival as first-line monotherapy, but the population is exclusively Chinese, the trial is sponsor-run (Akeso), and confirmation in global trials (HARMONi-3/7) is pending.
https://ecancer.org/en/news/28894-wclc-2026-late-breaking-harmoni-2-analysis-shows-ivonescimab-significantly-improves-overall-survival-versus-pembrolizumab-in-pd-l1-positive-advanced-nsclc

6. ARTEMIS-008: the B7-H3 ADC risvutatug rezetecan improves survival in relapsed SCLC

[Congress] [China]
Open-label phase 3 (n = 461; more than 80% with prior immunotherapy) vs topotecan, presented at WCLC 2026. Median overall survival 18.5 vs 10.3 months (HR 0.46; 95% CI 0.35–0.62); PFS 7.2 vs 3.0 months; ORR 58.3% vs 12.6%. Grade ≥3 events: 60.9% vs 78.2%.
Why it matters: an unusual effect size in a disease with few options, but the trial is open-label, China-only, and sponsored (Hansoh/GSK); the global trial is needed before practice changes outside China.
https://www.news-medical.net/news/20260914/Ris-Rez-improves-survival-in-patients-with-relapsed-small-cell-lung-cancer.aspx

7. Sevabertinib: first-line accelerated approval in HER2-mutant NSCLC

[Regulatory FDA] [United States]
On September 9 the FDA extended the accelerated approval of this oral HER2 inhibitor to untreated patients (SOHO-01, n = 69): ORR 75% (95% CI 64–85%); 73% of responders maintained response ≥6 months and 38% ≥12 months. Conversion depends on the phase 3 SOHO-02.
Why it matters: single-arm data without a comparator; together with DESTINY-Lung04 it opens the debate on optimal sequencing in HER2-mutant NSCLC.
https://www.cancernetwork.com/view/fda-gives-accelerated-approval-to-sevabertinib-in-her2-nsclc

8. Ifinatamab deruxtecan application withdrawn in relapsed SCLC

[Regulatory FDA] [United States / Japan]
On September 25 Daiichi Sankyo and Merck voluntarily withdrew the accelerated approval application for I-DXd (a B7-H3 ADC) after FDA discussions: the phase 2 IDeate-Lung01 data (n = 137; ORR 48.2%; PFS 4.9 months) were insufficient. The companies will await the phase 3 IDeate-Lung02, with overall survival as the endpoint (completion expected in 2028).
Why it matters: a signal that the FDA expects randomized survival data for ADCs in SCLC, just as ARTEMIS-008 provides them for another B7-H3 agent.
https://www.onclive.com/view/ifinatamab-deruxtecan-bla-voluntarily-withdrawn-in-previously-treated-extensive-stage-sclc

3. Hematologic oncology

9. CERVINO: the bispecific etentamig cuts the risk of progression by 60% in triple-class–exposed myeloma

[Clinical trial] [International]
Phase 3 (n = 393) vs investigator's choice (carfilzomib-dexamethasone, elotuzumab-pomalidomide-dexamethasone, or selinexor-bortezomib-dexamethasone). PFS HR 0.40 (95% CI 0.29–0.54); ORR 74.0% vs 45.7%. Cytokine release syndrome 28.3% (no grade ≥3), ICANS 0.9%; grade 3–4 infections 27.7% vs 19.2%. Results presented at IMS 2026.
Why it matters: a favorable safety profile for a BCMA bispecific, although the comparators are weak and the data come from the sponsor (AbbVie) without peer-reviewed publication yet.
https://www.onclive.com/view/etentamig-meets-dual-primary-end-points-in-triple-class-exposed-r-r-myeloma

10. Pirtobrutinib: approved in China for all lines of CLL/SLL and in the U.S. for first line

[Regulatory NMPA/FDA] [China / United States]
The NMPA approved this noncovalent BTK inhibitor on September 28 for CLL/SLL in any line; the FDA approved it on October 2 for untreated CLL/SLL (without 17p deletion). Basis: BRUIN CLL-313 (n = 282; vs bendamustine-rituximab: 80.1% reduction in risk of progression or death) and BRUIN CLL-314 (n = 662; noninferior ORR vs ibrutinib).
Why it matters: the CLL-313 comparator is outdated; its place versus acalabrutinib or zanubrutinib in first line is undefined, and cost weighs heavily in settings like the Dominican Republic.
https://www.cancernetwork.com/view/pirtobrutinib-earns-approval-in-china-for-cll-sll-across-all-therapy-lines
https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

11. IMS 2026: sustained MRD negativity with DVRd in CEPHEUS and real-world CAR-T data from China

[Congress] [International / China]
In CEPHEUS (n = 395, newly diagnosed myeloma, transplant-ineligible or deferred), daratumumab-VRd achieved MRD negativity in 61.4% vs 39.9% with VRd. A Chinese real-world series with equecabtagene autoleucel (n = 281, relapsed myeloma) reported ORR 95.9%, complete or stringent complete response 77.2%, and 12-month PFS 71.5%.
Why it matters: CEPHEUS supports quadruplet therapy in transplant-ineligible patients; the CAR-T data are observational, uncontrolled, and single-country, useful as a feasibility benchmark rather than comparative efficacy.
https://www.targetedonc.com/view/ims-2026-day-4-mrd-guided-regimens-real-world-car-t-data

4. Screening, prevention, supportive care, radiotherapy and surgical oncology

12. NRG-CC009: radiosurgery vs hippocampal-avoidant whole-brain radiotherapy for SCLC brain metastases

[Clinical trial] [United States]
Randomized phase 3 (n = 151) presented at ASTRO 2026. It missed its neurocognitive primary endpoint, but radiosurgery was associated with longer overall survival (median 17.4 vs 8.6 months; adjusted HR 0.60; 95% CI 0.39–0.91) with comparable intracranial control.
Why it matters: it challenges routine whole-brain radiotherapy in SCLC; survival was a secondary endpoint and the sample is small, so the full publication should be awaited.
https://www.oncology-central.com/astro-2026-stereotactic-radiosurgery-shows-an-overall-survival-benefit-for-sclc-brain-metastases/

13. Hypofractionated postmastectomy radiotherapy: 3 weeks matches 5 weeks at ten years

[Clinical trial] [China]
Phase 3 (n = 810 analyzed; high-risk breast cancer) comparing 15 fractions over 3 weeks vs 25 over 5 weeks to the chest wall and supraclavicular region, presented at ASTRO 2026 (September 28). 10-year locoregional recurrence 12.0% vs 10.3% (not significantly different); overall survival 77.5% vs 72.9%. Similar late toxicity, with more asymptomatic lung fibrosis (20% vs 12%).
Why it matters: long follow-up supporting hypofractionation after mastectomy, with a direct impact on radiotherapy capacity in the region; single-country and mostly without breast reconstruction.
https://www.curetoday.com/view/three-weeks-of-radiation-after-mastectomy-works-as-well-as-five-10-year-data-show

14. ROAM/EORTC-1308: radiotherapy after resection of atypical meningioma

[Publication] [United Kingdom / Europe]
International phase 3 (n = 157, 11 countries; resected grade 2 meningioma) published in The Lancet on September 25. 5-year recurrence 14% with radiotherapy vs 30% with observation; no differences in quality of life or neurocognitive function.
Why it matters: the first randomized trial to answer this question; it supports adjuvant radiotherapy, although overall survival is not yet mature.
https://news.liverpool.ac.uk/2026/09/25/radiotherapy-halves-the-risk-of-brain-tumour-returning-after-surgery/

15. FDA advisory panel backs the Galleri multi-cancer early detection test

[Regulatory FDA] [United States]
On September 23 the Molecular and Clinical Genetics Panel voted 10-0 on safety, 7-2-1 on benefit–risk, and 6-4 on effectiveness, for adults ≥50 years as an adjunct to standard screening. In PATHFINDER 2 and NHS-Galleri: 12-month sensitivity 35.0% and 31.6%; specificity 99.85% and 99.74%; PPV 77.0% and 66.2%. NHS-Galleri did not reduce the incidence of stage III–IV cancer.
Why it matters: a panel vote is not approval; without evidence of reduced mortality or late-stage disease, it should not displace breast, cervical, and colorectal screening, whose coverage in the region is still low.
https://www.onclive.com/view/fda-mcgp-panel-vote-backs-galleri-multi-cancer-early-detection-test

Cross-cutting

Other FDA actions in the period: lirafugratinib for previously treated FGFR2-altered cholangiocarcinoma (September 23), shortened post–first-infusion observation for tarlatamab to 6–8 hours, and a label update for taletrectinib in ROS1-positive NSCLC (September 17). In Brazil, ANVISA approved fruquintinib for pretreated metastatic colorectal cancer (August 31; source in Portuguese). Regionally, we found no new SLACOM or Dominican Society of Oncology guidelines this month, no verifiable DIGEMAPS or COFEPRIS actions, and no relevant AI publications with a confirmed date in the period.
https://opovo.com.br/trends/anvisa-aprova-nova-opcao-para-cancer-colorretal-metastatico-que-age-sobre-vasos-usados-pelo-tumor-para-crescer/

Upcoming meetings and dates

• ESMO Congress 2026: Madrid, October 23–27, 2026 (47 oral presentations from Chinese groups; late-breaking abstract titles released September 25).

Monthly oncology bulletin — October 4, 2026

15 verified items from the past month: WCLC 2026, IMS 2026, ASTRO 2026, The Lancet, and FDA, NMPA, and ANVISA decisions.

Three worth your time:
• HARMONi-2: ivonescimab beat pembrolizumab on overall survival in PD-L1+ NSCLC (30.8 vs 22.6 months; HR 0.73). Caveat: Chinese population only.
• ARTEMIS-008: the B7-H3 ADC risvutatug rezetecan nearly doubled survival vs topotecan in relapsed SCLC (18.5 vs 10.3 months). Caveat: open-label, regional trial.
• DESTINY-Lung04: first-line T-DXd in HER2-mutant NSCLC improved PFS (14.3 vs 8.3 months) with no overall survival benefit and 21% pneumonitis.

Full bulletin, with a critical appraisal of each study and links to primary sources:
https://boletinesmedicos.com/en/oncologia/2026-10-04.html

#Oncology #Cancer #LungCancer #Myeloma #RadiationOncology

Oncology, Sept 2026: ivonescimab beats pembrolizumab on OS in PD-L1+ NSCLC (30.8 vs 22.6 mo; HR 0.73, China only). First-line T-DXd in HER2-mutant NSCLC: PFS 14.3 vs 8.3 mo, no OS gain. https://boletinesmedicos.com/en/oncologia/2026-10-04.html