The 2026 ASCO Annual Meeting (May 29–June 2, Chicago) has delivered multiple late-breaking results with direct formulary and access implications. This recap covers the five plenary presentations, key oral sessions, and the payer-relevant takeaways from each — updating the evidence landscape that access teams, payer strategists, and oncology pharmacists need to track.
This article follows our ASCO 2026 pipeline evidence preview published before the meeting. Here we focus on the actual data readouts and their practical implications.
Five studies to track
| Study | Drug | Setting | Key result | Regulatory status |
|---|---|---|---|---|
| OptiTROP-Lung05 | Sac-TMT + pembrolizumab | First-line PD-L1+ NSCLC | PFS HR 0.35, ORR 70% | sNDA accepted (China); MSD global Phase III program |
| HARMONi-6 (LBA4) | Ivonescimab + chemo | First-line squamous NSCLC | OS results at plenary | China-approved; global HARMONi-3 ongoing |
| PROTEUS (LBA1) | Apalutamide + ADT | Perioperative prostate cancer | pCR and MFS results at plenary | Erleada FDA-approved (nmCRPC, mCSPC); expansion filing possible |
| RASolute 302 (LBA5) | Daraxonrasib | Previously treated pancreatic cancer | OS ~13.2 vs 6.7 months | FDA CNPV program; NDA planned |
| WU-KONG28 (LBA) | Sunvozertinib | First-line EGFR exon20ins NSCLC | PFS 10.3 vs 7.5 months (HR 0.65) | NDA filed (China) |
Sac-TMT plus pembrolizumab: first ADC + IO success in first-line NSCLC
Trial: OptiTROP-Lung05 (NCT06448312) — Sacituzumab tirumotecan (sac-TMT, Kelun-Biotech / MSD) plus pembrolizumab vs. pembrolizumab monotherapy in first-line PD-L1 TPS ≥1% advanced NSCLC.
Design: 413 patients, 1:1 randomization. Sac-TMT 4 mg/kg Q2W + pembrolizumab 400 mg Q6W vs. pembrolizumab 400 mg Q6W. Median follow-up 10.5 months.
Results (presented May 29, Abstract 8506, simultaneously published in The Lancet):
| Endpoint | Sac-TMT + Pembrolizumab | Pembrolizumab alone | HR (95% CI) | p-value |
|---|---|---|---|---|
| Median PFS (BICR) | Not reached | 5.7 months | 0.35 (0.26–0.47) | <0.0001 |
| 12-month PFS rate | 62.4% | 29.0% | — | — |
| OS (immature) | NR vs 14.5 months | — | 0.55 (0.36–0.85) | — |
| 12-month OS rate | 80.4% | 68.9% | — | — |
| ORR | 70.2% | 42.0% | — | — |
| Deep response rate | 49.0% | 25.9% | — | — |
The PFS benefit was consistent across PD-L1 subgroups: TPS 1–49% HR 0.28 (0.19–0.41), TPS ≥50% HR 0.47 (0.29–0.77). Both histologies benefited: non-squamous HR 0.28 (0.18–0.43), squamous HR 0.44 (0.29–0.66).
Safety: Grade ≥3 treatment-emergent AEs: 55.3% (combo) vs. 31.4% (pembro alone). Most common Grade ≥3 events: decreased neutrophil count (17.3%), anemia (9.1%), stomatitis (5.3%). Discontinuation of pembrolizumab due to TEAEs was similar between arms. No sac-TMT-related deaths occurred.
Formulary implications:
- This is the first phase 3 trial to demonstrate PFS benefit of an ADC added to pembrolizumab in first-line PD-L1+ NSCLC, potentially challenging the current standard of pembrolizumab monotherapy in PD-L1 TPS ≥1% patients
- Sac-TMT (developed by Kelun-Biotech; ex-China rights licensed to MSD in a deal valued up to $1.4 billion) has sNDA accepted for priority review by China's NMPA
- MSD is running 17 global Phase III studies with sac-TMT across multiple tumor types. A global first-line NSCLC filing would compete directly with Keytruda monotherapy — which generated nearly $31.7 billion in 2025 revenue
- Payers should prepare utilization management pathways for ADC + IO combinations, including documentation of PD-L1 status and histology, if global filing and approval occur
Ivonescimab: PD-1/VEGF bispecific reports OS from HARMONi-6
Trial: HARMONi-6 (NCT05840016, LBA4) — Ivonescimab (Akeso / Summit Therapeutics) plus platinum-based chemotherapy vs. tislelizumab (Tevimbra) plus chemo in first-line advanced squamous NSCLC.
Context: Ivonescimab is a first-in-class PD-1×VEGF bispecific antibody developed by Akeso (China), with ex-China rights licensed to Summit Therapeutics. It became the first China-developed drug to earn an ASCO plenary slot in the meeting's six-decade history.
What is known before the plenary presentation (May 31):
- HARMONi-6 previously showed PFS benefit over tislelizumab + chemo in Chinese patients with newly diagnosed squamous NSCLC
- The key question at plenary is overall survival: ivonescimab would be the first regimen to demonstrate an OS benefit over a PD-1/chemotherapy combination in first-line NSCLC in a phase 3 trial
- The statistical plan set an OS stopping boundary at HR 0.722 (27.8% improvement needed)
- The study enrolled predominantly Chinese male smokers, which could limit translatability to a global population
- In a setback, Summit's global HARMONi-3 trial missed its interim PFS analysis in the squamous cohort, raising questions about the China-to-global translatability
Formulary implications:
- A positive OS result from HARMONi-6 would support China-market positioning but the HARMONi-3 miss complicates any near-term US/EU filing
- If ivonescimab eventually reaches global markets, it would create a new class of bispecific checkpoint/antiangiogenic agents with distinct coding and reimbursement considerations
- Payers should monitor whether the OS benefit, if demonstrated, extends to non-squamous histology and a more diverse global population
PROTEUS: perioperative Erleada in localized prostate cancer
Trial: PROTEUS (NCT03767244, LBA1) — Apalutamide (Erleada, J&J) + ADT vs. placebo + ADT, given perioperatively (6 months neoadjuvant + radical prostatectomy + 6 months adjuvant) in high-risk localized or locally advanced prostate cancer.
Context: Approximately 2,000 patients enrolled at >203 sites in 18 countries. Primary endpoints: pathologic complete response (pCR) and metastasis-free survival (MFS). The phase 2 Apa-RP precursor study showed 100% biochemical recurrence-free survival at 24 months.
Erleada generated nearly $3.6 billion in global sales in 2025 from its current indications (non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer). A positive PROTEUS result would expand Erleada into the localized disease setting, which accounts for more than 85% of all prostate cancer diagnoses at presentation.
Formulary implications:
- Perioperative ADT + AR inhibitor would be a new treatment paradigm for surgically managed high-risk prostate cancer
- Duration of therapy (12 months total) is shorter than metastatic indications, but the eligible patient population is much larger
- Pathology-driven treatment decisions (pCR after neoadjuvant therapy) would require new care pathway coordination between urology, medical oncology, and pathology
- Access teams should prepare for potential NCCN guideline updates and payer coverage criteria that require documentation of high-risk features (Gleason score, pelvic node status)
Daraxonrasib: first RAS(ON) inhibitor shows OS benefit in pancreatic cancer
Trial: RASolute 302 (NCT06625320, LBA5) — Daraxonrasib (Revolution Medicines) vs. chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (mPDAC).
Results:
- OS approximately 13.2 vs. 6.7 months — roughly doubling overall survival versus standard chemotherapy in previously treated pancreatic cancer
- Daraxonrasib is a first-in-class oral agent that acts as a "molecular glue," binding to cyclophilin A to block signaling of multiple RAS-mutant variants (G12, G13, Q61)
- RAS mutations drive more than 90% of pancreatic cancers; daraxonrasib targets the broad RAS(ON) signaling rather than individual mutations
- FDA selected daraxonrasib for the Commissioner's National Priority Voucher (CNPV) pilot program; Revolution Medicines intends to submit a New Drug Application and has initiated an expanded access program
Formulary implications:
- If approved, daraxonrasib would be the first RAS(ON) inhibitor in any indication — creating a new drug class for payer coding and reimbursement
- Early reports describe "profound tumor shrinkage and a doubling of the median overall survival compared with historical chemotherapy benchmarks"
- Pancreatic cancer has limited treatment options and poor prognosis; payers may apply less restrictive utilization management than for more competitive oncology settings
- Monitor companion diagnostic requirements — the drug targets RAS mutations broadly, but specific testing protocols have not been finalized
Additional practice-changing data
Sunvozertinib in EGFR exon 20 insertion NSCLC
The WU-KONG28 phase 3 trial showed sunvozertinib (Dizal Pharma) achieved median PFS of 10.3 vs. 7.5 months versus platinum-based chemotherapy (HR 0.65, p=0.0008) as first-line treatment for EGFR exon 20 insertion NSCLC. Confirmed ORR was 58.9% vs. 31.1%. NDA filed in China.
This competes with amivantamab (Rybrevant) + lazertinib, which showed PFS benefit in the MARIPOSA trial. If sunvozertinib reaches global markets, payers would face a two-drug competitive landscape in EGFR exon 20 NSCLC.
CROWN: seven-year OS update for lorlatinib
The CROWN trial (Abstract 8502) reported seven-year follow-up data for lorlatinib (Lorbrena, Pfizer) in ALK-positive metastatic NSCLC. At a median follow-up of 83 months, median PFS remains unreached with a 7-year PFS rate of 55% (vs. 3% with crizotinib; HR 0.19), and 44% of patients remain on lorlatinib treatment. OS data remain formally immature as the protocol-specified number of events has not yet been reached. No new intracranial progression events occurred after month 30. These results reinforce lorlatinib as a preferred first-line option for ALK+ NSCLC with exceptionally durable disease control — among the longest PFS ever reported in advanced solid tumors.
Enhertu: early-stage breast cancer approval
On May 15, 2026 (presented at ASCO), the FDA approved trastuzumab deruxtecan (Enhertu) for two HER2-positive early-stage breast cancer indications: neoadjuvant treatment followed by THP, and adjuvant treatment for residual invasive disease after neoadjuvant HER2-targeted therapy. Two companion diagnostic devices were concurrently approved. This expands Enhertu from the metastatic setting into early-stage disease, substantially increasing the eligible patient population.
BREAKWATER in BRAF-mutant colorectal cancer
The BREAKWATER trial (updated results first presented at ASCO 2025) reported median OS of 30.3 vs. 15.1 months with encorafenib + cetuximab + mFOLFOX6 in BRAFV600E-mutant metastatic colorectal cancer (HR 0.49, 51% reduction in death risk). This doubles the historical survival benchmark for this molecular subtype.
Datroway: first-line TNBC approval
On May 22, 2026, the FDA approved datopotamab deruxtecan (Datroway) for first-line metastatic TNBC. See our Datroway TNBC coverage guide for full access details.
What access teams should do now
Sac-TMT + pembrolizumab: Track MSD's global Phase III program and potential US filing. If approved, this would change first-line NSCLC treatment pathways for PD-L1+ patients — the single largest oncology market segment by revenue. Prepare formulary review frameworks that evaluate ADC + IO combinations.
Daraxonrasib: Monitor FDA Commissioner's National Priority Voucher program timeline and NDA submission. Revolution Medicines has initiated an expanded access program for eligible patients. If approved, establish HCPCS coding, buy-and-bill workflows, and RAS mutation testing protocols. The drug's mechanism (RAS(ON) inhibition via tri-complex with cyclophilin A) creates a novel reimbursement category.
PROTEUS / Erleada expansion: If positive, prepare for NCCN guideline updates in localized prostate cancer. The perioperative setting requires coordination between surgical and medical oncology — establish prior authorization workflows that support the 12-month treatment duration.
Enhertu early breast cancer: Update formulary positioning to include the early-stage indications. Verify companion diagnostic coverage (PATHWAY anti-HER-2/neu 4B5 and VENTANA HER2 Dual ISH) for neoadjuvant patient selection.
Sunvozertinib vs. amivantamab: If sunvozertinib reaches global markets, prepare comparative effectiveness reviews for EGFR exon 20 insertion NSCLC — a growing competitive niche.
What to monitor next
- HARMONi-6 plenary (May 31): Whether ivonescimab demonstrates statistically significant OS benefit in squamous NSCLC — and how the global HARMONi-3 miss is contextualized
- Daraxonrasib FDA review: Timeline and any advisory committee meeting
- Sac-TMT global filings: Whether MSD initiates a US/EU filing based on OptiTROP-Lung05 or waits for a global registrational trial
- NCCN guideline updates: Expected updates reflecting ASCO 2026 data in NSCLC, prostate cancer, breast cancer, and colorectal cancer
- Payer policy bulletins: Major payers typically issue coverage policy updates within 60–90 days of major ASCO data releases
Sources
- Kelun-Biotech. "Phase III OptiTROP-Lung05 Study of Sacituzumab Tirumotecan (Sac-TMT) Presented as ASCO Oral Presentation and Published in The Lancet." PR Newswire, May 29, 2026. https://www.prnewswire.com/news-releases/the-results-of-phase-iii-optitrop-lung05-study-of-sacituzumab-tirumotecan-sac-tmt-presented-as-an-asco-oral-presentation-and-simultaneously-published-in-the-lancet-302786204.html
- OncologyTube. "ASCO 2026 Top 5 Practice-Changing Abstracts: Ivonescimab Dominates + 4 More Game-Changers." 2026. https://oncologytube.com/asco-2026-top-5-practice-changing-abstracts
- Fierce Pharma. "ASCO Preview: Expectations Jacked as Akeso Ivonescimab Faces Scrutiny in High-Stakes Plenary." 2026. https://www.fiercepharma.com/pharma/asco-preview-expectations-jacked-akeso-ivonescimab-face-scrutiny-high-stakes-plenary
- ASCO. "Abstract 8506: OptiTROP-Lung05 Phase 3 Study." https://www.asco.org/abstracts-presentations/259330
- OncologyTube. "ASCO 2026 Day 1 Highlights: Sunvozertinib 10.3 mo PFS & Sac-TMT 65% Risk Reduction." 2026. https://oncologytube.com/asco-2026-day-1-highlights-sunvozertinib-sac-tmt-nsclc
- OncLive. "OptiTROP-Lung05 Shows PFS Benefit With First-Line Sac-TMT Plus Pembrolizumab in PD-L1 NSCLC." 2026. https://www.onclive.com/view/optitrop-lung05-shows-pfs-benefit-with-first-line-sac-tmt-plus-pembrolizumab-in-pd-l1-nsclc
- Cancer Therapy Advisor. "ASCO 2026 to Highlight Latest Developments in Lymphoma, Lung, Breast Cancers." 2026. https://www.cancertherapyadvisor.com/reports/asco-2026-to-highlight-latest-developments-in-lymphoma-lung-breast-cancers
- FDA. "FDA Approves Two Separate Indications for Fam-Trastuzumab Deruxtecan-nxki in HER2-Positive Early-Stage Breast Cancer." May 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage
- Oncology News Central. "ASCO 2026: First Featured Studies Introduce Potential New Standards." 2026. https://www.oncologynewscentral.com/oncology/asco-2026-first-featured-studies-introduce-potential-new-standards
- PharmaPhorum. "Late-Breakers Look Out: ASCO 2026." 2026. https://pharmaphorum.com/news/late-breakers-look-out-asco-2026
- Pfizer. "Seven-Year Analysis from Pfizer's LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced NSCLC." May 29, 2026. https://www.pfizer.com/news/press-release/press-release-detail/seven-year-analysis-pfizers-lorbrena-crown-trial-shows
- Revolution Medicines. "Daraxonrasib Demonstrates Unprecedented Overall Survival Benefit in Pivotal Phase 3 RASolute 302 Clinical Trial." April 13, 2026. https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit
- Merck & Co. 2025 Annual Report. Keytruda (pembrolizumab) worldwide revenue. https://www.merck.com/wp-content/uploads/2026/02/2025-Annual-Report.pdf
