Goldman Sachs: ASCO 2026 highlights progress in Japanese pharma oncology pipelines, but Ono's ONO-4578 still needs more Phase III validation

Overview

This report summarizes the investment implications for Goldman Sachs' covered Japanese pharmaceutical companies following clinical data disclosures at the ASCO 2026 annual meeting, focusing on Ono Pharmaceutical's ONO-4578, IBI363/TAK-928 developed by Takeda in partnership with Innovent, and potential competitors faced by Daiichi Sankyo's Datroway and Astellas' setidegrasib.

Core views

Goldman Sachs believes the Phase II results for ONO-4578 are overall positive, but exploratory subgroup analysis suggests the patient population with high efficacy may be limited, so more data and Phase III results are needed before forming higher expectations for the drug. The disclosed data for IBI363/TAK-928 and sac-TMT do not change the existing judgment for now. Data for daraxonrasib are favorable, but have not yet changed the view on setidegrasib; future development progress in first-line PDAC and other indications by both sides should be closely monitored.

Analysis framework

Based on clinical trial abstracts and released information disclosed at ASCO, the report evaluates the investment implications for covered Japanese pharmaceutical companies around indications, trial design, PFS, OS, ORR, safety, subgroup performance, competitor positioning, and Goldman Sachs' DCF valuation framework.

Methodology notes

• Valuation methods12-year DCF

  12-year DCF valuation

  The target prices for Ono, Takeda, Daiichi Sankyo, and Astellas are all based on a 12-year DCF model, assuming a WACC of 6% and a terminal growth rate of 0%.

• clinical_trial_analysisPFS/OS/ORR and subgroup analysis

  Clinical endpoint evaluation and subgroup analysis

  The report uses progression-free survival, overall survival, objective response rate, hazard ratios, safety events, and subgroups such as PD-L1 and KRAS to assess drug data quality and the applicable patient population.

• factor_profileGS Factor Profile

  Goldman Sachs factor profile

  This framework compares growth, financial returns, valuation multiples, and composite factors to provide investment context for the stock relative to the broader market and industry peers.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Ono Pharmaceutical (4528.T)

  Core covered company; ONO-4578 data directly affect expectations for its oncology pipeline

  Strengths

  ONO-4578 showed improvements in PFS, OS, and ORR in the overall population and the PD-L1-positive subgroup, with no new safety concerns identified.

  Weaknesses

  No clear benefit was shown in the PD-L1-negative or indeterminate population, the exploratory subgroup sample size was small, and the high-efficacy population may be limited.

  Comparison

  Compared with placebo plus standard treatment, the ONO-4578 combination group had PFS of 9.0 months versus 6.9 months for the control group.

  Risks

  Phase III failure, a narrowing applicable patient population, Opdivo indication expansion or market share below expectations, and lower-than-expected sales of key drugs.

• Takeda Pharmaceutical (4502.T)

  Co-developer of IBI363/TAK-928

  Strengths

  IBI363/TAK-928 showed efficacy across different histologies and PD-L1 expression subgroups in first-line NSCLC.

  Weaknesses

  The data are still at an early stage, and the rate of Grade 3 or above treatment-related adverse events is relatively high.

  Comparison

  The 3-1.5 mg/kg regimen was recommended as the first-line NSCLC dose after considering both efficacy and safety.

  Risks

  R&D delays or discontinuation, changes in product assessment, changes in drug pricing systems, and financial risks related to large M&A.

• Daiichi Sankyo (4568.T)

  Datroway may face competition from sac-TMT

  Strengths

  Goldman Sachs believes Datroway can still differentiate through safety and convenience in addition to efficacy.

  Weaknesses

  sac-TMT disclosed favorable data in first-line NSCLC, creating medium- to long-term competitive pressure.

  Comparison

  sac-TMT had a PFS HR of 0.35 in OptiTROP-Lung05; future comparison will be needed against Datroway-related AVANZAR and TROPION-Lung series data.

  Risks

  Negative news in the ADC business, weaker-than-expected sales of key drugs, and changes in global drug pricing and healthcare systems.

• Astellas Pharma (4503.T)

  setidegrasib faces observation of KRAS-targeted competitors such as daraxonrasib

  Strengths

  Astellas is advancing a global Phase III first-line trial in metastatic PDAC with KRAS G12D mutation.

  Weaknesses

  daraxonrasib showed favorable OS in a Phase III trial in second-line and later PDAC, potentially raising the competitive bar.

  Comparison

  Median OS for daraxonrasib versus investigator's choice chemotherapy was 13.2 months vs 6.7 months.

  Risks

  setidegrasib clinical data below expectations, accelerated competitor development, and negative news around Padcev and Vyloy.

Key data

• ONO-4578 first-line gastric cancer Phase II PFS9.0 months vs 6.9 months; P=0.040; HR=0.67ONO-4578 plus nivolumab and chemotherapy extended PFS versus the placebo combination group.
• ONO-4578 PD-L1-positive subgroupPFS 9.9 months vs 5.7 months; OS not reached vs 12.7 months; ORR 70.9% vs 50.9%Clinical benefit was more evident in the PD-L1-positive population, i.e., CPS≥1.
• ONO-4578 safetyNo new safety concerns identifiedHowever, no clear benefit was shown in the PD-L1-negative or indeterminate population.
• IBI363/TAK-928 ORR in the recommended-dose groupConfirmed ORR was 81.8% in the 3-1.5 mg/kg groupThis regimen was recommended for first-line NSCLC; ORR was 76.9% in PD-L1-negative patients.
• IBI363/TAK-928 treatment-related adverse events of Grade 3 or above43.5% in the 3-1.5 mg/kg group, 50.0% in the 1.5 mg/kg group, 69.0% in the 3 mg/kg groupSafety is an important basis for dose selection.
• sac-TMT OptiTROP-Lung05 PFSMedian PFS not reached vs 5.7 months; HR=0.35sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line NSCLC with PD-L1 TPS≥1%.
• daraxonrasib RASolute 302 OS13.2 months vs 6.7 months; HR=0.40For previously treated metastatic PDAC; OS HR was 0.38 in KRAS G12D/V mutations.
• Ono Pharmaceutical rating and target priceSell; 12-month target price ¥2,100Based on a 12-year DCF, WACC 6%, terminal growth rate 0%.
• Takeda Pharmaceutical rating and target priceNeutral; 12-month target price ¥5,600Key risks include sales of key drugs, R&D delays, changes in drug pricing and healthcare systems, and financial risks from large M&A.
• Daiichi Sankyo rating and target priceBuy; 12-month target price ¥4,300Key risks include lower-than-expected sales of core drugs, negative news in the ADC business, and changes in global drug pricing policy.
• Astellas Pharma rating and target priceBuy; 12-month target price ¥2,950Key risks include sales of core drugs, R&D delays, and negative news related to Padcev and Vyloy.

Impact & implications

The report's implication for Ono is somewhat cautious: although ONO-4578 has shown positive clinical progress, the range of beneficiary patients and the reproducibility in subsequent Phase III studies remain key to a valuation re-rating. For Takeda, the IBI363/TAK-928 data provide early support but are not yet sufficient to materially change the investment view. For Daiichi Sankyo and Astellas, competitor data reinforce future pipeline competitive pressure, but Goldman Sachs has not yet adjusted its core views on Datroway and setidegrasib.

Risks

• Phase III results for ONO-4578 may fail to replicate the benefit seen in the overall Phase II population or the PD-L1-positive subgroup.
• The high-efficacy patient population for ONO-4578 may be narrow, limiting peak commercialization sales expectations.
• Early efficacy data for IBI363/TAK-928 may weaken in larger samples or subsequent trials, and safety events require continued observation.
• Progress by competitors such as sac-TMT and daraxonrasib may compress the differentiation space for Datroway or setidegrasib.
• Changes in drug pricing and healthcare systems, especially policy changes in the US and global markets, may affect the revenues and valuations of Japanese pharmaceutical companies.
• R&D discontinuation, clinical delays, changes in product assessment, and lower-than-expected sales of key drugs.

What to watch

• The design, enrollment scope, and subsequent data of Ono's global Phase III gastric cancer trial for ONO-4578 planned to start within the year.
• Data disclosure from IBI363/TAK-928 US Phase II trial NCT06281678.
• Data from the Datroway-related AVANZAR trial, expected to be disclosed in 2H2026.
• Results from the TROPION-Lung07 and TROPION-Lung08 trials and their comparison with the sac-TMT TroFuse program.
• Progress of Astellas setidegrasib global Phase III first-line metastatic PDAC trial NCT07409272.
• Progress of RVMD daraxonrasib RASolute303 and zoldonrasib RASolute305 and RASolute309 trials.