Top 10 Oncology Drug Clinical Data Highlights from ASCO 2023

From June 2 to June 6, 2023, the American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago, USA. At this academic feast, world-class oncology experts gathered together, and clinical data of products from pharmaceutical companies in and outside China were showcased. This article compiles clinical data of 10 popular drugs for reference.

NO.1 SKB264 Data on Advanced Non-Small Cell Lung Cancer Published for the First Time (Poster, 9114)

SKB264 is a next-generation antibody-drug conjugate (ADC) jointly developed by Kelun-Biotech and Merck, composed of a humanized monoclonal antibody targeting TROP2, an enzymatically cleavable linker, and a novel topoisomerase I inhibitor, combining the specificity of monoclonal antibodies for tumor cell surface target antigens with the high efficacy of cytotoxic drugs.

At this year's ASCO conference, the Phase II expansion study data of SKB264 for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) was released for the first time. This is a multicenter dose-escalation and expansion study, which had enrolled 43 patients as of February 9, 2023, with a median follow-up time of 11.5 months and a median treatment duration of 5.7 months.

The results showed that 39 patients with NSCLC were evaluable for efficacy (received SKB264 5 mg/kg, Q2W), with an objective response rate (ORR) of 44% (17/39), a disease control rate (DCR) of 95% (37/39), a median duration of response (DoR) of 9.3 months, and a 6-month DoR rate of 77%.

In the EGFR mutation subgroup, all patients were resistant to EGFR-TKI, 50% of the patients had received at least one chemotherapy regimen, ORR was 60% (12/20), DCR was 100% (20/20), median progression-free survival (PFS) was 11.1 months, and the 9-month PFS rate was 66.7%. In the EGFR wild-type subgroup, all patients had failed PD-1/L1 antibody treatment, the median number of prior treatments was 2, ORR was 26% (5/19), DCR was 89% (17/19), median PFS was 5.3 months, and the 9-month OS rate was 80.4%.

In terms of safety, the most common ≥ Grade 3 treatment-related adverse events (TRAEs) (≥ 5%) were decreased neutrophil count, anemia, decreased white blood cell count, oral mucositis, rash, and decreased lymphocyte count. Most hematologic-related adverse events occurred within two months after starting SKB264 treatment and resolved after treatment with granulocyte colony-stimulating factor or erythropoietin. The proportion of TRAEs leading to dose reduction was 23.3%, with no discontinuations or deaths due to TRAEs. No neurotoxicity or drug-related interstitial lung disease (ILD)/non-infectious pneumonia was observed.

NO.2 DESTINY-CRC02: Phase II Study of DS-8201 in HER2+ Metastatic Colorectal Cancer(Oral Report, 3501)

Trastuzumab Deruxtecan (T-DXd, DS-8201), an antibody-drug conjugate (ADC) targeting HER2 developed collaboratively by AstraZeneca and Daiichi Sankyo, has been approved for indications including HER2-positive breast cancer, gastric cancer, and gastroesophageal junction cancer. The results presented at ASCO are from the Phase II DESTINY-CRC02 study evaluating T-DXd in HER2+ metastatic colorectal cancer (mCRC).

DESTINY-CRC02 is a randomized, double-blind, multicenter Phase II clinical trial designed to evaluate the efficacy and safety of T-DXd (5.4 and 6.4 mg/kg) in patients with HER2+mCRC. The study enrolled a total of 122 participants. In the first phase, 80 patients were randomly assigned 1:1 to receive either 5.4 (n=40) or 6.4 (n=40) mg/kg T-DXd Q3W. In the second phase, an additional 42 patients received 5.4 mg/kg T-DXd. The primary endpoint was the confirmed objective response rate (cORR) assessed by the Blinded Independent Central Review Committee (BICR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

As of the data cutoff date (November 1, 2022), the majority of patients in the 5.4 and 6.4 mg/kg T-DXd groups were HER2 IHC3+ (78.1% and 85.0%), had RAS wild-type tumors (82.9% and 85.0%), and had previously received a median of 3 and 4 lines of therapy, respectively.

The results showed that the cORR was 37.8% (95% CI, 27.3-49.2%) in the 5.4 mg/kg group and 27.5% (95% CI, 14.6-43.9%) in the 6.4 mg/kg group. Key efficacy endpoints are shown in the table below.

In terms of safety, the incidence rates of treatment-emergent adverse events (AEs) of Grade ≥3 in the 5.4 mg/kg and 6.4 mg/kg groups were 49.4% and 59.0%, respectively, while the incidence rates of serious AEs were 24.1% and 30.8%, respectively. The independently assessed incidence rates of drug-related interstitial lung disease were 8.4% and 12.8%, respectively, with the majority being Grade 1/2 (one case of Grade 5 in the 6.4 mg/kg group).

NO.3 COMMANDS: Luspatercept Phase III Study for First-Line Treatment of Anemia in Adults with MDS (Oral Presentation, 7003)

Luspatercept, developed by Bristol-Myers Squibb, is an erythroid maturation agent that has been approved for two indications: β-thalassemia and myelodysplastic syndromes. The data presented at the ASCO meeting was from the Phase III COMMANDS study of Luspatercept (Reblozyl) as a first-line treatment for anemia in adult patients with lower-risk myelodysplastic neoplasms (MDS).

COMMANDS is a randomized, open-label, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of luspatercept versus erythropoiesis-stimulating agent (ESA) epoetin-α in patients with anemia due to very low- to intermediate-risk MDS. The study enrolled 347 patients who were randomly assigned to receive either luspatercept or epoetin-α. The primary endpoint was red blood cell transfusion independence for 12 weeks (RBC-TI) with an increase in mean hemoglobin (Hb) levels by ≥1.5 g/dL. Key secondary endpoints included erythroid response (HI-E) for at least 8 weeks during weeks 1-24, and RBC-TI for ≥12 weeks and 24 weeks.

As of August 31, 2022, 178 patients received luspatercept treatment (subcutaneous injection once every 3 weeks, starting dose 1.0 mg/kg, titrated to 1.75 mg/kg), and 176 patients received epoetin alfa treatment (once weekly, starting dose 450 IU/kg, titrated to 1050 IU/kg), with median treatment durations of 41.6 weeks and 27 weeks, respectively. Among them, 147 patients in the luspatercept group and 154 patients in the epoetin alfa group were evaluable.

The results showed that 58.5% of patients (n=86) in the luspatercept group reached the primary endpoint of the study, which was to achieve red blood cell transfusion independence for 12 weeks (RBC-TI) within the first 24 weeks and an increase in average hemoglobin (Hb) levels by ≥1.5g/dL, compared to 31.2% (n=48) in the recombinant human erythropoietin group (p<0.0001).

For secondary endpoints, 74.1% (n=109) of patients in the luspatercept group achieved at least 8 weeks of erythroid response, compared to 51.3% (n=79) in the recombinant human erythropoietin group (p<0.0001). Patients treated with luspatercept achieved a more durable treatment response compared to those treated with recombinant human erythropoietin, with a median response duration for RBC-TI >12 weeks (from week 1 to the end of treatment) of 126.6 weeks vs. 77 weeks. Within the first 24 weeks of treatment, 47.6% (n=70) of patients in the luspatercept group achieved 24 weeks free from red blood cell transfusions, compared to 29.2% (n=45) in the recombinant human erythropoietin group (P=0.0006).

In clinically relevant subgroups, investigators also observed benefits brought by luspatercept, with results showing a consistent safety profile and no new safety signals emerging. Luspatercept is the first and only therapy to demonstrate superiority over ESAs in head-to-head comparisons for TD LR-MDS patients, representing an innovative treatment for anemia associated with lower-risk MDS.

NO.4 MORPHEUS-liver: Tiragolumab Combination Therapy Phase Ib/II Study for First-Line Treatment of Liver Cancer (Clinical Science Symposium, 4010)

Tiragolumab is a TIGIT monoclonal antibody that Roche has high hopes for. However, last year, Tiragolumab stumbled in two important lung cancer indications. In March 2022, Roche announced that the Phase III SKYSCRAPER-02 study of Tiragolumab in combination with atezolizumab and chemotherapy for the first-line treatment of extensive-stage small cell lung cancer did not meet the co-primary endpoint of PFS. In May of the same year, more bad news came: the Phase III SKYBUILDINGER-01 study of Tiragolumab in combination with atezolizumab versus atezolizumab alone for the first-line treatment of PD-L1 high-expression NSCLC patients did not reach the primary endpoint of PFS.

At this year's ASCO conference, Roche presented data from the Phase Ib/II MORPHEUS-liver study investigating Tiragolumab in combination with Atezolizumab and Bevacizumab as a first-line treatment for patients with unresectable locally advanced or metastatic hepatocellular carcinoma (uHCC). The study enrolled 58 previously untreated uHCC patients who were randomly assigned to receive either Atezolizumab (1200mg IV) + Bevacizumab (15mg/kg IV) every 3 weeks or Tiragolumab (600mg IV) + Atezolizumab + Bevacizumab.

As of November 28, 2022, the median follow-up time for the Tiragolumab combination therapy group was 14.0 months, compared to 11.8 months in the control group. The confirmed ORR in the Tiragolumab combination therapy group was 42.5%, higher than 11.1% in the control group; the median PFS in the Tiragolumab combination therapy group was 11.1 months (95% CI, 8.2-NE), while it was 4.2 months (95% CI, 1.6-7.4) in the control group, with an HR of 0.42 (95% CI, 0.22-0.82). Similar ORR and PFS benefits were observed in the Tiragolumab combination therapy group across both the PD-L1+ (n=23) and PD-L1- (n=27) subgroups.

In terms of safety, the incidence of grade 3/4 treatment-related adverse events (AEs) was 27.5% in the control group and 33.3% in the Tiragolumab + Atezolizumab + Bevacizumab group, while AEs leading to any treatment interruption occurred in 22.5% and 22.2% of patients, respectively. No new safety signals were identified.

NO.5 ATTRACTION-5: Adjuvant Treatment with Nivolumab Combined with Chemotherapy for pStage III Gastric Cancer or Gastroesophageal Junction (G/GEJ) Tumors - Phase III Study (Oral Presentation, 4000)

Nivolumab (Opdivo), a PD-1 monoclonal antibody developed by Bristol-Myers Squibb, has been approved for multiple indications including non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, esophageal cancer, and gastric cancer since its market launch in December 2014.

ATTRACTION-5 is the first Phase III study to evaluate immune checkpoint inhibitors combined with adjuvant chemotherapy for pStage III G/GEJ cancer. The confirmatory results of adjuvant treatment with Nivolumab + Chemotherapy (N+C) post-surgery were reported for the first time at the ASCO meeting.

ATTRACTION-5 is a randomized, double-blind, multicenter Phase III clinical trial conducted in Japan, South Korea, Taiwan, and mainland China. The primary endpoint is centrally assessed recurrence-free survival (RFS). The sample size was calculated based on the results of the ACTS-GC and CLASSIC studies (assuming a hazard ratio [HR] of 0.67; assuming 3-year RFS of 71% vs. 60%). Secondary endpoints include investigator-assessed RFS, overall survival (OS), and the 3-year RFS and OS rates.

From February 2017 to August 2019, a total of 755 patients were randomized, with 377 assigned to the N + C group and 378 assigned to the placebo plus chemotherapy (P + C) group. The final analysis of RFS was based on the clinical data cutoff date in August 2022, with a minimum follow-up of 36 months after the last patient was randomized.

The results showed that the study did not meet the primary efficacy endpoint of centrally assessed RFS (HR, 0.90; 95% CI, 0.69-1.18; P=0.4363). The 3-year RFS rate was 68.4% (95% CI, 63.0-73.2) in the N+C group and 65.3% (95% CI, 59.9-70.2) in the P+C group. The completion rate of planned postoperative adjuvant therapy was 61.5% in the N+C group and 71.4% in the P+C group.

In terms of safety, the incidence rates of Grade 3 TRAEs, serious TRAEs, and TRAEs leading to discontinuation in the N+C group were 54.4%, 25.3%, and 9.2%, respectively, while those in the P+C group were 46.8%, 10.7%, and 3.5%, respectively.

NO.6 TORCHLIGHT: Phase III Study of Toripalimab in Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) (Oral Presentation, LBA1013)

Toripalimab is the first China-produced monoclonal antibody drug targeting PD-1 approved for marketing in China. To date, the company has initiated more than 40 clinical studies covering over 15 indications globally (including China, the United States, Southeast Asia, and Europe).

TORCHLIGHT is a randomized, double-blind, placebo-controlled multicenter Phase III clinical study aimed at comparing the efficacy and safety of toripalimab in combination with injectable paclitaxel (albumin-bound) versus placebo in combination with injectable paclitaxel (albumin-bound) in patients with newly diagnosed Stage IV or recurrent metastatic triple-negative breast cancer (TNBC). This study is the first Phase III clinical trial in China to achieve positive results in the field of immunotherapy for advanced TNBC.

The study enrolled a total of 531 patients with newly diagnosed stage IV or recurrent metastatic TNBC, who were randomly assigned at a 2:1 ratio to receive either toripalimab (240mg, Q3W, n=353) or placebo in combination with nab-P (125mg/m², on days 1 and 8, Q3W, n=178) until disease progression or the occurrence of intolerable toxicity. Among these, there were 200 PD-L1 positive patients in the toripalimab group and 100 in the placebo group. The primary endpoint was PFS assessed by BICR according to RECIST 1.1 criteria in both the PD-L1 positive population and the intention-to-treat (ITT) population. Secondary endpoints included OS, investigator-assessed PFS, ORR, DOR, and safety.

As of November 30, 2022, the median follow-up time was 14 months. The results showed that in the PD-L1 positive population, compared with placebo combined with nab-P, the PFS of the Toripalimab combined with nab-P group was significantly prolonged (the median PFS evaluated by BICR were 8.4 vs 5.6 months), reducing the risk of disease progression or death by 35%. The 1-year PFS rates and 2-year PFS rates of the two groups were 41.9% vs 24.4% and 23.5% vs 14.5%, respectively.

PFS in PD-L1 Positive Population Assessed by BICR

Key subgroup analysis of the PD-L1 positive population showed that PFS benefits from Toripalimab combined with nab-P were observed regardless of PD-L1 expression level (CPS≥10 or 1≤CPS<10), physical condition, disease status, metastatic sites, or prior treatment history. A similar trend of PFS benefit was also observed in the ITT population. The median PFS assessed by BICR was 8.4 vs 6.9 months (Toripalimab combined with nab-P group vs placebo combined with nab-P group), HR=0.77 (95% CI 0.60-0.99). The 1-year and 2-year PFS rates for the two groups were 41.1% vs 29.8% and 20.5% vs 11.3%, respectively.

The interim OS analysis showed that a significant OS benefit trend was observed in both the PD-L1 positive population and the ITT population for the combination of toripalimab and nab-P.

In the PD-L1 positive population, compared with placebo combined with nab-P, toripalimab combined with nab-P treatment prolonged patient OS (32.8 vs 19.5 months), HR=0.62 (95%CI 0.41-0.91); in the ITT population, the OS of the toripalimab combined with nab-P group was also superior to the placebo combined with nab-P group (33.1 vs 23.5 months), HR=0.69 (95%CI 0.51-0.93).

In terms of safety, the incidence of ≥3 grade adverse events (AE, 56.4% vs 54.3%) and fatal AEs (0.6% vs 3.4%) were similar between the two groups, with no new safety signals detected. Additionally, the most common TEAEs (incidence ≥20%) and the most common irAEs (incidence ≥2%) were generally consistent in both groups.

NO.7 NATALEE: Phase III Study of Ribociclib as Adjuvant Therapy for Early Breast Cancer (Oral Presentation)LBA500）

Ribociclib, a CDK4/6 inhibitor developed by Novartis, blocks the proliferation of cancer cells by preventing tumor cells from transitioning from the G1 phase to the S phase.

NATALEE is a randomized, open-label global multicenter Phase III clinical trial designed to evaluate the efficacy and safety of ribociclib in combination with endocrine therapy (ET) as adjuvant treatment for patients with HR+/HER2- early breast cancer (EBC). The study enrolled 5,101 patients with Stage II or III EBC at risk of recurrence, who were randomly assigned to receive either ribociclib (400 mg/day) + ET or ET alone. The primary endpoint is invasive disease-free survival (iDFS), with secondary endpoints including safety, quality of life, and overall survival.

The results showed that compared with ET alone, ribociclib combined with ET reduced the risk of cancer recurrence by 25.2% (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014) in patients with stage II or III HR+/HER2- EBC. Meanwhile, it demonstrated consistent and clinically meaningful iDFS benefits in key pre-specified subgroups.

All secondary efficacy endpoints also achieved positive results, including distant disease-free survival (DDFS) (26% risk reduction) and recurrence-free survival (RFS) (28% risk reduction), with a trend toward improvement in overall survival (OS) (HR=0.759; 95% CI: 0.539, 1.068).

In terms of safety, the incidence of symptomatic adverse events (AEs) was low, and there was less need for dose adjustment over up to three years of treatment. The most frequently reported specific adverse events (Grade 3 or higher) were neutropenia (43.8%) and liver-related adverse events (such as elevated transaminases) (8.3%). The incidence of Grade 3 or higher QT interval prolongation and diarrhea in the Kisqali group was low, at 1.0% and 0.6%, respectively.

This is the world's first and only Phase III CDK4/6 inhibitor adjuvant study to achieve positive results in a broad Phase II and III EBC population.

NO.8 ADAURA: OS Analysis of Osimertinib Adjuvant Therapy for EGFR-Positive Stage IB-IIIA NSCLC (Plenary Session, LBA3)

Osimertinib (Tagrisso), a third-generation EGFR T790M inhibitor developed by AstraZeneca, has been approved for the treatment of non-small cell lung cancer (NSCLC) in multiple regions, including China, the United States, Europe, and Japan. The overall survival (OS) results from its ADAURA study were presented at the ASCO conference.

ADAURA is a randomized, double-blind, placebo-controlled Phase III clinical trial. The study enrolled 682 patients with Stage IB to IIIA EGFR mutation-positive NSCLC who had undergone complete tumor resection, and they were randomly divided into two groups in a 1:1 ratio to receive either osimertinib or placebo. The primary endpoint was DFS in patients with Stage II to IIIA disease; secondary endpoints included DFS in the overall population (Stage IB to IIIA), OS, and safety.

Data with a median follow-up of 44.2 months presented at the ESMO Annual Meeting 2022 showed that, in patients with stage Ⅱ to ⅢA disease, the median DFS was 65.8 months vs 21.9 months in the two groups, with osimertinib reducing the relative risk of disease recurrence or death by 77% (HR=0.23); in the overall population, the median DFS was 65.8 months vs 29.1 months, with osimertinib reducing the relative risk of disease recurrence or death by 73% (HR=0.27), confirming the sustained DFS benefit of adjuvant osimertinib treatment.

The results presented at the ASCO meeting showed that in patients with stage II/IIIA NSCLC, the median follow-up times for OS were 59.9 months (osimertinib group) and 56.2 months (placebo group), respectively. The 5-year OS rates were 85% in the osimertinib group and 73% in the placebo group (HR=0.49, 95.03% CI: 0.33-0.73, P=0.0004), with a 12% absolute benefit at 5 years.

In the overall population (Stage Ib, II, IIIA), the median follow-up times for OS were 60.4 months (Osimertinib group) and 59.4 months (Placebo group), respectively. The 5-year OS rates for the Osimertinib group and Placebo group were 88% and 78%, respectively (HR=0.49, 95.03% CI: 0.34-0.70, P<0.0001), with a 10% benefit at 5 years. The median OS for patients in both groups with Stage IB-IIIA has not yet been reached.

In terms of subsequent treatment, compared with the osimertinib group, a higher proportion of patients in the placebo group received EGFR-TKIs. In the placebo group (n=343), 184 (54%) patients received subsequent anti-tumor treatment, of which 162 patients received EGFR-TKI treatment and 79 patients received osimertinib treatment.

Moreover, the results indicate that patients can benefit from adjuvant treatment with osimertinib regardless of disease stage, whether or not they received adjuvant chemotherapy, or whether they have the ex19del or L858R mutation. The safety profile is consistent with the primary analysis of the ADAURA study.

NO.9 INDIGO: Vorasidenib Phase III Study in IDH1/2-Mutant Grade 2 Glioma (Plenary Session, LBA1)

Vorasidenib, developed by Servier, is an oral, brain-penetrant, and selective investigational dual inhibitor that can inhibit mutant IDH1/2 proteins. Currently, this product is in Phase III clinical trials and is the most advanced IDH1/2 inhibitor in development.

In March this year, Servier announced that the Phase III INDIGO study of vorasidenib monotherapy for patients with residual or recurrent IDH-mutant low-grade glioma met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The pre-specified interim analysis results were statistically significant and clinically meaningful. Detailed data from this study were presented at the ASCO meeting.

INDIGO is one of the few large Phase III clinical trials in the glioma field to yield positive results in nearly 20 years, aside from chemotherapy. This was a multicenter, randomized, double-blind, placebo-controlled study that enrolled 331 patients with residual or recurrent grade 2 oligodendroglioma or astrocytoma who harbored IDH1 or IDH2 mutations and had only undergone surgery as treatment prior to enrollment. Participants were randomly assigned in a 1:1 ratio to receive either vorasidenib (n=168) or placebo (n=163). After a median follow-up of 14.2 months, 226 patients (68.3%) continued to receive either vorasidenib or placebo.

The results showed that the median PFS for vorasidenib was 27.7 months compared to 11.1 months in the placebo group (HR=0.39; 95% CI, 0.27-0.56; one-sided P=0.000000067). Regarding secondary endpoints, the median TTNI for vorasidenib has not yet been reached, while it was 17.8 months in the placebo group (HR=0.26; 95% CI, 0.15-0.43; one-sided P=0.000000019).

In terms of safety, 22.8% of patients in the vorasidenib group experienced grade 3 or higher adverse events, compared to 13.5% in the placebo group, with the most common being elevated alanine aminotransferase levels.

CARTITUDE-4: Phase III Study of Carvykti in Relapsed/Refractory Multiple Myeloma (Clinical Science Symposium, LBA106)

Cilta-cel (Ciltacabtagene Autoleucel, trade name: Carvykti) is a BCMA CAR-T therapy jointly developed by Legend Biotech and Johnson & Johnson. It has been approved in the United States, the European Union, and Japan for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy.

In January this year, Johnson & Johnson and Legend Biotech announced that the Phase III CARTITUDE-4 study of Cilta-cel for the treatment of RRMM patients who had received 1-3 prior lines of therapy had met its primary endpoint. In a pre-specified interim analysis, Cilta-cel significantly improved progression-free survival (PFS) in adult RRMM patients compared to standard therapy. In April this year, an abstract presented at the European Hematology Association (EHA) annual meeting showed that Cilta-cel reduced the risk of disease progression by 74%. These findings exceeded the expectations of industry analysts. The latest results from this study were presented at the ASCO meeting.

CARTITUDE-4 is a randomized, open-label international Phase III study designed to evaluate the efficacy and safety of Cilta-cel compared with standard treatment regimens of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received one to three lines of therapy. The study randomly assigned 419 patients to two treatment groups: cilta-cel (n=208) and SOC (n=211). The primary endpoint is PFS, and secondary endpoints include safety, overall survival (OS), minimal residual disease (MRD) negativity rate, and overall response rate (ORR).

Results showed that at a median follow-up of 16 months, the median PFS in the SOC group was 11.8 months (95% CI, 9.7–13.8), while the median PFS in the cilta-cel group had not yet been reached (95% CI, 22.8–NE). In patients previously treated with first-line therapy, there was a 65% reduction in the risk of disease progression or death (hazard ratio 0.35, 95% CI, 0.19–0.66, P < 0.0001). For secondary endpoints, the overall response rate (ORR) in the cilta-cel group was 85%, with 73% of patients achieving complete response (CR) or better, and the overall minimal residual disease (MRD) negativity rate reached 61%. In contrast, in patients receiving SOC treatment, the ORR was 67%, with 22% achieving CR or better, and the MRD negativity rate was 33%.

In terms of safety, 97% and 94% of patients in the cilta-cel group and SOC group, respectively, experienced grade 3 or 4 adverse events, including infections (27% vs 25%) and cytopenia (94% vs 86%). Overall, there were 39 and 46 deaths in the cilta-cel group and SOC group, respectively, with 10 and 5 patients dying from treatment-related adverse events. Among patients treated with cilta-cel (n=176), 76% experienced cytokine release syndrome (CRS) (1% grade 3, no grade 4 or 5), 5% experienced immune effector cell-associated neurotoxicity syndrome (all grade 1 or 2), and there was one case of grade 1 motor and neurocognitive adverse events.

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