What's next in oncology — October 14, 2026

This edition covers five milestones with verifiable dates between mid-November and late December 2026: four pending FDA decisions (lung, breast and myeloma) and the San Antonio Breast Cancer Symposium. PDUFA dates are target review dates, not approvals: the agency can act early, extend the review or issue a complete response letter.

1. Ivonescimab + chemotherapy in EGFR-mutant NSCLC after TKI

[Pending regulatory decision] [USA] [Confirmed date: November 14, 2026]
What it is: A PD-1/VEGF bispecific antibody with carboplatin and pemetrexed versus placebo plus the same chemotherapy in locally advanced or metastatic non-squamous EGFR-mutant NSCLC that progressed on a TKI (HARMONi, phase 3, double-blind; 438 patients randomized). PFS HR 0.52 (95% CI 0.41–0.66; median 6.8 vs 4.4 months); in the primary analysis (April 2025 cutoff) overall survival, a co-primary endpoint, was not statistically significant (HR 0.79; 95% CI 0.62–1.01; p = 0.057; median 16.8 vs 14.0 months). With longer follow-up, OS HRs of 0.78 (nominal p = 0.0332; September 2025 cutoff) and 0.76 (June 2026 cutoff) were reported, without formal testing. The FDA accepted the BLA on January 29, 2026.
What problem it solves: After progression on osimertinib, platinum-based chemotherapy remains the standard, with limited benefit; PD-1 inhibitors alone have not helped in EGFR-mutant disease.
Critical take: Company-sponsored; approval would rest on PFS without a significant OS benefit in the primary analysis (later updates are descriptive); in that primary analysis the OS HR in Western patients was 0.98, and much of the earlier evidence comes from a Chinese population (HARMONi-A).
https://www.sec.gov/Archives/edgar/data/1599298/000159929826000006/a2026_prx0129xfdablaacce.htm
https://www.businesswire.com/news/home/20260129109846/en/
https://www.onclive.com/view/ivonescimab-plus-chemotherapy-sustains-os-benefit-in-pretreated-egfr-mutated-nsclc

2. Neladalkib in pretreated ALK-positive NSCLC

[Pending regulatory decision] [USA] [Confirmed date: November 27, 2026]
What it is: A selective, CNS-penetrant ALK inhibitor active against resistance mutations (including G1202R) for advanced ALK+ NSCLC previously treated with a TKI; priority review (announced by Nuvalent on May 27, 2026) and breakthrough therapy designation, based on the phase 1/2 ALKOVE-1 trial (NCT05384626).
What problem it solves: After lorlatinib or compound resistance mutations, targeted options are scarce and patients move to chemotherapy.
Critical take: Single-arm, open-label evidence with objective response rate as the phase 2 primary endpoint (a surrogate); there are no randomized data in this pretreated setting.
https://investors.nuvalent.com/2026-05-27-Nuvalent-Announces-Key-Program-and-Business-Updates,-Strengthening-Foundation-for-Global-Leadership-in-ROS1-and-ALK-positive-NSCLC
https://clinicaltrials.gov/study/NCT05384626

3. Adjuvant giredestrant in early ER+/HER2− breast cancer

[Pending regulatory decision] [USA] [Confirmed date: November 30, 2026]
What it is: An oral SERD versus standard endocrine therapy in intermediate- or high-risk stage I–III disease (lidERA, open-label phase 3, NCT04961996, >4,100 patients); at the interim analysis, iDFS HR 0.70 (95% CI 0.57–0.87; p = 0.0014), 92.4% vs 89.6% at 3 years; priority review (FDA acceptance announced by Roche on June 2, 2026).
What problem it solves: Late recurrences persist despite 5–10 years of tamoxifen or aromatase inhibitors, and adherence is a problem; according to Roche, it is the first and only oral SERD with positive phase 3 results in the curative setting.
Critical take: Roche-sponsored; open-label trial; a 2.8-point absolute difference at 3 years with immature OS, and cost versus generic endocrine therapy in our setting remains to be seen.
https://www.roche.com/media/releases/med-cor-2026-06-02
https://clinicaltrials.gov/study/NCT04961996

4. Anitocabtagene autoleucel (anito-cel) in relapsed multiple myeloma

[Pending regulatory decision] [USA] [Confirmed date: December 23, 2026]
What it is: An anti-BCMA CAR-T for relapsed or refractory myeloma after ≥3 prior lines (fourth line); in the single-arm phase 2 iMMagine-1 (NCT05396885, n = 117 treated; 87% triple-refractory) the company reports an overall response rate of 96% and CR/sCR of 74% at a median follow-up of 15.9 months (ASH, December 2025).
What problem it solves: Adds another anti-BCMA CAR-T where current options carry delayed neurotoxicity (parkinsonism) or manufacturing and access constraints; in the analysis presented at ASH 2025, no delayed (non-ICANS) neurotoxicities, including parkinsonism, were reported.
Critical take: Single-arm study without a comparator, with company-reported data (Kite/Gilead); CAR-T access in Latin America and the Caribbean remains very limited.
https://www.businesswire.com/news/home/20260223744889/en/
https://www.gilead.com/news/news-details/2025/kite-announces-new-data-for-pivotal-immagine-1-study-at-ash-2025-highlighting-anito-cels-opportunity-in-relapsed-or-refractory-multiple-myeloma
https://clinicaltrials.gov/study/NCT05396885

5. San Antonio Breast Cancer Symposium 2026

[Congress] [USA] [Confirmed date: December 8, 2026]
What it is: SABCS 2026, December 8–11 at the Henry B. Gonzalez Convention Center in San Antonio, Texas, hosted by UT Health San Antonio and the AACR; an annual meeting dedicated to new breast cancer data.
What problem it solves: It usually features phase 3 results in hormone receptor-positive disease, targeted therapy and antibody-drug conjugates that often feed the following year's guideline updates.
Critical take: Many presentations are interim analyses or abstracts without full peer review; wait for publication before changing practice.
https://www.aacr.org/about-the-aacr/newsroom/media-advisories/media-registration-now-open-san-antonio-breast-cancer-symposium-2026-december-8-11/

*What's next in oncology — October 14, 2026*

Five milestones with official dates (FDA target dates, not approvals):

• Nov 14: ivonescimab + chemo in EGFR-mutant NSCLC after TKI (better PFS; OS not significant in the primary analysis)
• Nov 27: neladalkib in pretreated ALK+ NSCLC (priority review; phase 1/2)
• Nov 30: adjuvant giredestrant in early ER+/HER2− breast cancer (iDFS HR 0.70)
• Dec 23: anito-cel, anti-BCMA CAR-T in myeloma after ≥3 lines
• Dec 8–11: San Antonio Breast Cancer Symposium

Full text and audio:
https://boletinesmedicos.com/en/oncology/2026-10-14-viene.html
MedBulletins · boletinesmedicos.com/en/

What's next in oncology (November–December 2026), with an official source for every date:

1. Nov 14 — FDA decision on ivonescimab + chemotherapy in EGFR-mutant NSCLC after TKI. PFS gain; the co-primary OS endpoint was not significant in the primary analysis.
2. Nov 27 — Neladalkib in pretreated ALK+ NSCLC, on phase 1/2 data.
3. Nov 30 — Adjuvant giredestrant in early ER+/HER2− breast cancer (lidERA, iDFS HR 0.70; OS immature).
4. Dec 23 — Anito-cel, anti-BCMA CAR-T for myeloma after ≥3 lines (single-arm study).
5. Dec 8–11 — SABCS 2026.

Target dates, not approvals. Critical take on each item in the full text and audio:
https://boletinesmedicos.com/en/oncology/2026-10-14-viene.html

#Oncology #LungCancer #BreastCancer #MultipleMyeloma #MedicalBulletins

What's next in oncology: FDA decisions on ivonescimab (Nov 14), neladalkib (Nov 27), adjuvant giredestrant (Nov 30) and anito-cel (Dec 23); SABCS Dec 8–11. Critical take:
https://boletinesmedicos.com/en/oncology/2026-10-14-viene.html