ASCO 2026 Highlights: Akeso's AK112 Shows Strong Data in 2L SCLC; InnoCare's Mesutoclax Demonstrates Potential in Hematologic Malignancies

Overview

This report summarizes key data from Days 4-5 of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting by Morgan Stanley, focusing on the latest clinical advances in China's biotechnology sector. The core views center on two potential blockbuster drugs: first, Akeso's bispecific antibody AK112 (ivonescimab) combined with liposomal irinotecan in second-line small cell lung cancer (SCLC); and second, InnoCare's Bcl-2 inhibitor Mesutoclax in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The report suggests that although some data come from single-arm trials or small sample sizes, preliminary results show competitive efficacy and safety profiles, which could reshape relevant treatment landscapes if subsequent durability data is confirmed. The firm maintains an 'Attractive' rating on the China Healthcare sector.

Core views

Akeso's AK112 Demonstrates Strong Efficacy and Safety in Second-Line SCLC Demand/Efficacy Comparison: In second-line SCLC (2L SCLC) treatment, single-arm trial data for AK112 plus liposomal irinotecan (lipo-iri) showed an objective response rate (ORR) of 61.7%, disease control rate (DCR) of 96.7%, median progression-free survival (mPFS) of 8.1 months, 6-month PFS rate of 69.1%, and 12-month overall survival (OS) rate of 74%. In comparison, data from the IO-exp trial for BNT327 plus paclitaxel showed an ORR of 37.2%, mPFS of 5.4 months, and 6-month PFS of 46.1%. The AK112 regimen leads significantly across all metrics. Supply/Mechanism Breakdown: By comparing data from the RESILIENT trial for liposomal irinotecan monotherapy (ORR 44.1%, mPFS 4.0 months), the report notes that chemotherapy establishes the 'floor' for response, while AK112's key contribution is enhancing treatment 'durability,' increasing mPFS from 4.0 to 8.1 months. Even in the chemotherapy-resistant subgroup (CFI<90), AK112 still achieved an mPFS of 6.7 months. Risk/Safety Considerations: The incidence of Grade ≥3 treatment-related adverse events (TRAE) in the AK112 group was 36.7%, and bleeding incidence was 20%, significantly lower than the 78.6% in the BNT327 group. The report notes that if bleeding risks and quality of life (QoL) impacts are manageable, AK112 displays an attractive risk-reward profile. However, it should be noted that the proportion of chemotherapy-sensitive patients in the AK112 single-arm trial differs (lower CFI<90 proportion, 36.7% vs. 50% for BNT327), which may be a confounding factor requiring further observation of durability data and potential dose adjustments. InnoCare's Mesutoclax Shows Differentiated Potential in Hematologic Malignancies High-Risk MDS (HR-MDS): In treatment-naive (TN) high-risk MDS patients (n=10), Mesutoclax combined with azacitidine (AZA) showed extremely high response rates, with an ORR of 100% and a composite complete remission rate (compCR) of 90% under IWG23 criteria. For comparison, competitor Lisaftoclax typically shows ORRs of 64-74% and compCRs of ~70%. The report emphasizes that despite small sample sizes and early-stage status, this signal is highly competitive, especially considering competitor VERONA trial failed to improve overall survival (OS). Future focus should be on OS, durability, and whether excessive hematologic toxicity occurs. Acute Myeloid Leukemia (AML): In treatment-naive AML patients (n=44), Mesutoclax plus AZA achieved a composite complete remission rate (cCR) of 81.8%, complete remission rate (CR) of 63.6%, and measurable residual disease (MRD) negativity rate of 86.5%. In contrast, Sonro (another Bcl-2 inhibitor) showed CR/CRi of 67.1%, MRD negativity of only 35.4%, Grade ≥3 infection incidence as high as 50.6%, and tumor lysis syndrome (TLS) incidence of 5%; Lisaftoclax showed CRc of 51%. Mesutoclax appears superior to existing standards or competitors in depth of response and safety (particularly infection risk). Close monitoring is needed for duration of response (DOR), OS, blood count recovery, and risk of infection/febrile neutropenia compared to standard azacitidine/venetoclax (AZA/VEN) therapy.

Analysis framework

The report employs a typical 'conference data breakdown and horizontal benchmarking' analytical method. First, core clinical endpoint data (e.g., ORR, mPFS, OS, AE) disclosed at ASCO were extracted for each key drug. Second, vertical decomposition was performed, such as breaking down combination therapy effects into 'chemotherapy baseline effect' and 'immunotherapy/targeted incremental effect' to assess the true contribution of new drugs (as seen in the AK112 case). Third, horizontal benchmarking was conducted by comparing trial data against historical controls, publicly available competitor data, or industry standard therapies (e.g., comparing Mesutoclax data with Lisaftoclax, Sonro, and AZA/VEN standard therapy) to judge relative competitive advantages. Finally, factors such as sample size, trial design (single-arm vs. randomized), and patient baseline characteristics (e.g., CFI status) were integrated to identify potential data biases or risk points, resulting in a cautiously optimistic assessment.

Methodology notes

• Industry Analysis Framework

  Clinical Trial Data Decomposition and Benchmarking Analysis

  When evaluating new drug potential, beyond looking at overall efficacy, combination therapies are decomposed into 'baseline chemotherapy effect' and 'new drug incremental effect,' and horizontally compared with historical data from competitors or standard therapies to eliminate bias from patient baseline differences and more accurately judge true clinical value.

• Industry Analysis Framework

  Risk/Reward Assessment

  When evaluating drug prospects, efficacy metrics (e.g., ORR, PFS) are weighed alongside safety metrics (e.g., Grade ≥3 AE, bleeding, infection), with special attention to drugs that maintain high efficacy while significantly reducing severe side effects, as this directly determines patient quality of life and medication adherence.

Asset mapping & comparison

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

• Akeso (9926.HK)

  Beneficiary: AK112 demonstrates superior efficacy and safety vs. competitors in 2L SCLC, with large potential market opportunity.

  Strengths

  ORR and mPFS significantly lead competitors; better safety profile (lower Grade ≥3 AE); mature bispecific antibody platform technology.

  Weaknesses

  Single-arm trial data lacking head-to-head randomized control; potential bias in CFI distribution; bleeding risk requires monitoring.

  Comparison

  Superior to BNT327+paclitaxel regimen; offers higher durability and lower toxicity compared to traditional chemo-immunotherapy combinations.

  Risks

  Risk of failure in subsequent randomized trials; dose interruption due to bleeding or QoL impact; regulatory approval uncertainty.

• InnoCare Pharma (9969.HK)

  Beneficiary: Mesutoclax shows high response rates and deep remission capability in MDS and AML, potentially replacing or supplementing existing standard therapies.

  Strengths

  100% ORR in MDS; high MRD negativity rate in AML; infection risk appears lower than competitors/standard therapy.

  Weaknesses

  Small sample size (MDS n=10, AML n=44); early-stage data; lack of long-term OS and durability data.

  Comparison

  MDS data superior to Lisaftoclax; AML data superior to Sonro and AZA/VEN standard therapy in terms of MRD negativity and infection rates.

  Risks

  Shadow of VERONA trial failure; inability to replicate early results in subsequent large trials; hematologic toxicity risk; intensified competition.

Key data

• AK112/lipo-iri (2L SCLC) ORR61.7%Significantly higher than 37.2% for BNT327+paclitaxel
• AK112/lipo-iri (2L SCLC) mPFS8.1 monthsSignificantly higher than 5.4 months for BNT327+paclitaxel
• AK112/lipo-iri (2L SCLC) Grade ≥3 TRAE36.7%Significantly lower than 78.6% for BNT327+paclitaxel
• Mesutoclax+AZA (TN HR-MDS) ORR100%Sample size n=10, early-stage data
• Mesutoclax+AZA (TN HR-MDS) compCR90%Higher than ~70% for Lisaftoclax
• Mesutoclax+AZA (TN AML) cCR81.8%Sample size n=44
• Mesutoclax+AZA (TN AML) MRD Negativity Rate86.5%Significantly higher than 35.4% for Sonro

Impact & implications

The report believes that if AK112's data in second-line SCLC can be replicated in larger randomized trials, it will establish its leading position in this field, potentially becoming a new standard of care given its significantly superior safety profile versus competitors. For InnoCare, early data for Mesutoclax in MDS and AML suggests it may overcome resistance or safety issues associated with existing Bcl-2 inhibitors (e.g., venetoclax), particularly in reducing infection risk and achieving deep remissions; if supported by post-VERONA durability data, it is poised to capture significant share in the hematologic malignancy market. These developments reinforce the competitiveness of Chinese biopharma companies in global innovative drug R&D.

Risks

• Uncertainty of clinical trial results: Early or small-sample data may fail to replicate in subsequent large-scale randomized trials.
• Safety risks: Bleeding risk and QoL impact from AK112 may necessitate dose adjustment or interruption, affecting efficacy.
• Competitive risks: Rapid progress of other drugs in same class (e.g., other Bcl-2 inhibitors, bispecifics) may erode first-mover advantage.
• Regulatory approval risks: New drug applications may face stringent regulatory requirements or delays.
• Data bias: Differences in patient baseline characteristics (e.g., chemotherapy sensitivity) when comparing single-arm trials to historical controls may lead to overestimation of efficacy.

What to watch

• Durability data and final OS results for AK112 in larger randomized controlled trials.
• Incidence and management strategies for bleeding events during AK112 treatment, and impact on patient quality of life.
• Long-term overall survival (OS) and duration of response (DOR) data for InnoCare's Mesutoclax in MDS and AML.
• Whether excessive hematologic toxicity or differences in infection/febrile neutropenia rates versus standard therapy emerge in subsequent Mesutoclax trials.
• Regulatory approval progress for new indications of AK112 and Mesutoclax.