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ac4C RNA Modification and Epigenetic Therapies in DLBCL

KEY TAKEAWAYS The study aimed to investigate NAT10's role and mechanisms in DLBCL using clinical samples and various assays. The results showed the essential role of ac4C RNA modification mediated by NAT10 in DLBCL and provided insights into novel epigenetic-based...

Jul 5, 2024

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Efficacy of Durvalumab + Gemcitabine + Cisplatin in Advanced BTC

KEY TAKEAWAYS

  • The TOPAZ-1 phase 3 trial aimed to assess the efficacy and safety of the durvalumab + gemcitabine + cisplatin as a first-line treatment for BTC in a real-world setting .
  • The primary endpoint was OS.
  • Real-world analysis supported gemcitabine, cisplatin, and durvalumab as standard first-line treatment for advanced BTC.

This phase 3 trial demonstrated a survival benefit with anti-PD-L1 durvalumab when combined with gemcitabine and cisplatin (durvalumab + gemcitabine + cisplatin) for patients (pts) with advanced biliary tract cancer (BTC).

Andrea Casadei Gardini and the team designed this trial to further understand efficacy and tolerability of this combination, They conducted a worldwide multicenter retrospective analysis to evaluate its efficacy and safety as a new first-line standard treatment in a real-world setting in pts with advanced BTC.

The study included pts with unresectable, locally advanced, or metastatic BTC treated at 38 sites across 10 countries (Europe, United States, and Asia) with durvalumab + gemcitabine + cisplatin. The primary endpoint of the study was to evaluate overall survival (OS).

About 618 pts were enrolled in the study. As per the data cutoff on January 20, 2024, the median follow-up duration was 8.5 months (95% CI: 7.9-9.4). During this period, 52.9% pts discontinued to take the treatment due to disease progression, and 30.4% had died.

The median OS and progression-free survival (PFS) was 15.1 months (95% CI 13.4-29.1) and 8.1 months (95% CI 7.5-8.7) respectively. The overall response rate (ORR) was 31.7%, which comprised complete responses (CR) in 2.5% and partial responses (PR) in 29.6%. Stable disease (SD) was observed in 46.7% pts, concluding a disease control rate (DCR) of 78.8%.

Adverse events (AEs) of any grade occurred in 92.8% of pts, with grade 3-4 AEs were in reported in 46.0% of cases. The most frequent AEs included fatigue (55.1%), anemia (48.7%), neutropenia (46.0%), and thrombocytopenia (38.5%). Immune-mediated AEs (imAEs) occurred in 19.7% pts, with grade 3-4 imAEs in 2.5% of cases.

The analysis concluded that the real-world analysis largely validated the findings from the TOPAZ-1 trial, supporting durvalumab + gemcitabine + cisplatin as a standard first-line therapy for advanced BTC. This underscored the efficacy of the said treament and its potential as a clinical standard in pts with advanced BTC.

The trial was sponsored by AstraZeneca.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3

Clinical Trial: https://clinicaltrials.gov/study/NCT03875235

Gardini A C, Fornaro L, Lonardi S, et al. (2024). “Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: A large real-life worldwide population.” Presented at ESMO-GI 2024, (Abstract 293P)

Final Analysis of Pembro Plus Chemo in G/GEJ Cancer

KEY TAKEAWAYS

  • The KEYNOTE-585 phase 3 trial aimed to assess the efficacy and safety of perioperative pembro plus chemo in pts with G/GEJ cancer.
  • The primary endpoints were to determine pathCR (BICR), EFS, OS, and safety.
  • Researchers noticed that perioperative pembro plus chemo showed consistent efficacy and safety outcomes.

At 3 interim analysis (IA3) of KEYNOTE-585 (NCT03221426), perioperative pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo did not show significant improvement of event-free survival (EFS) in patients (pts) with untreated locally-advanced, resectable gastric and gastroesophageal junction (G/GEJ) cancer, although pathCR rate improved. A separate cohort evaluated pembro + FLOT.

Kohei Shitara and the team aimed to assess the efficacy and safety of perioperative pembro plus chemo in resectable G/GEJ cancer.

They performed an inclusive analysis involving eligible pts with untreated, locally advanced, resectable G/GEJ cancer. Patients were randomized 1:1 to receive either neoadjuvant pembrolizumab 200 mg IV Q3W or pbo plus chemo (cisplatin + capecitabine or cisplatin + 5-FU) for 3 cycles. Following surgery, pts received adjuvant pembro or pbo plus chemo Q3W for 3 cycles, followed by adjuvant pembro or pbo Q3W for 11 cycles in the main cohort.

In a separate FLOT cohort, pts were randomized 1:1 to receive pembro or pbo plus docetaxel, oxaliplatin, leucovorin, and 5-FU Q2W. The primary endpoints included pathologic complete response (pathCR) assessed by Blinded Independent Central Review (BICR), EFS evaluated by RECIST 1.1 and investigator criteria (INV), overall survival (OS) in the main cohort, and safety in the FLOT cohort. OS was not statistically assessed at final analysis due to the lack of positive results in EFS at the third IA3.

About 804 pts were randomized into the main cohort (402 pembro; 402 pbo) and 1007 into the main + FLOT cohort (502 pembro; 505 pbo). As of the data cut-off on February 16, 2024, median follow-up durations were 59.9 months and 58.6 months, respectively. In the main cohort, the pathCR rate was 13.4% (95% CI, 10.3-17.2) with pembro plus chemo compared to 2.0% (95% CI, 0.9-3.9) with pbo plus chemo (difference 11.4% [95% CI, 8.0-15.3]). At final analysis, median EFS was 44.4 months versus 25.5 months (HR 0.81; 95% CI, 0.67-0.99) and median OS was 71.8 months versus 55.7 months (HR 0.86; 95% CI, 0.71-1.06) with pembro plus chemo versus pbo plus chemo, respectively. Grade ≥3 drug-related adverse event (AEs) rates were 65% vs 63%.

The study concluded that efficacy and safety outcomes of neoadjuvant/adjuvant pembro plus chemo followed by adjuvant pembro in pts with untreated, locally advanced resectable G/GEJ cancer were consistent with prior analyses.

The trial was sponsored by the Merck Sharp & Dohme LLC.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/17

Clinical Trial: https://clinicaltrials.gov/study/NCT03221426

Shitara K, (2024). “Final analysis of the phase III KEYNOTE-585 study of pembrolizumab plus chemotherapy vs chemotherapy as perioperative therapy in locally-advanced gastric and gastroesophageal junction cancer.” Presented at ESMO-GI 2024 (Abstract LBA3).

Preoperative TACE + Immunotherapy Boosts HCC Outcomes

KEY TAKEAWAYS

  • The phase 2 & 3 trials aimed to investigate the efficacy of preoperative therapy TAСE + atezolizumab + bevacizumab in pts with HCC.
  • The primary endpoints were pCR, PR, QoL, and safety.
  • TAСE+immunotherapy improved ORR and presented minimal toxicity profiles.

Research of the combination of immunotherapy and transarterial chemoembolization (TACE) has become relevant: sintilimab+TACE, lenvatinib+pembrolizumab+TACE, durvalumab+bevacizumab+tremelimumab+TACE, lenvatinib+pembrolizumab+TACE.

Locoregional treatment in combination therapy improves the number of complete and partial responses (pathomorphological complete response (pCR) + partial response (PR)), overall, and disease-free survival rates (OS and DFS) with controlled toxicity.

Kate A. Nasonova and the team were determined to investigate the efficacy of preoperative therapy TAСE + atezolizumab + bevacizumab in patients (pts) with hepatocellular carcinoma (HCC) as neoadjuvant treatment before liver resection or OTP.

Researchers conducted the randomized, comparative research in parallel groups that included pts aged 18 to 69 with HCC T1-3N0M0, stages I-III, BCLC A-B, and Child-Pugh A to B7. The study comprised of 3 groups: group A comprised- pts waiting for transplantation who received combined bridge therapy (TACE + immunotherapy); in group – potentially resectable pts were included who received neoadjuvant therapy (TACE + immunotherapy); and group C included the control group, which received only TACE.

The primary endpoints were pCR + PR, quality of life (QoL), and safety as per CTCAE. Secondary endpoints were overall survival (OS) and DFS according to mRECIST criteria.

Results indicated that 21 pts received treatment, with a median follow-up of 12 months. The BCLC stages were: A in 9 pts (41%) and B in 13 pts (59%). Nineteen pts (86%) had liver cirrhosis, with 19 (90%) classified as Child-Pugh A and 2 (10%) as Child-Pugh B.

In terms of QoL and safety, 6 pts (28.6%) experienced thrombocytopenia, and there were no cases of gastrointestinal toxicity. Hepatic toxicity (ALT/AST) occurred in 6 pts (28.6%), renal toxicity in 6 (28.6%), and cardiotoxicity in 4 (19.1%). Neurological complications were observed in 1 patient (4.8%), proteinuria in 1 (4.8%), hypothyroidism in 2 (9.5%), itching in 4 (19.1%), and pulmonitis in 3 (14.3%). Infections and infestations were noted in 3 pts (14.3%), upper GI bleeding in 2 (9.5%), gastrointestinal mucosa erosion in 1 (4.8%), colitis in 6 (28.6%), adrenal insufficiency in 7 (33.3%), and anemia in 7 (33.3%).

Surgical treatment was given to 11 pts, with 7 (32%) undergoing liver resection and 4 (18%) undergoing transplantation. pCR by target node was achieved in 8 pts (72%), and PR by primary focus was observed in 3 pts (28%).

The study concluded that TAСE+immunotherapy improves ORR along with manageable toxicity profile.

The trials were sponsored by Zhejiang University, Merck Sharp & Dohme LLC and National Cancer Institute (NCI).

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3

Clinical Trials: https://www.clinicaltrials.gov/study/NCT04174781, https://www.clinicaltrials.gov/study/NCT04246177,
https://www.clinicaltrials.gov/study/NCT03937830

Nasonova K A, Zagidullina A A, Breder V V, et al. (2024). “Efficacy of the combination of transarterial chemoembolization (TACE) and immunotherapy of atezolizumab + bevacizumab in patients before liver resection and transplantation (OTP) with hepatocellular carcinoma (HCC).” Presented at ESMO-GC, (Abstract 170P)

STRIDE Maintains Survival Advantage in HCC

STRIDE Maintains Survival Advantage in HCC

KEY TAKEAWAYS

  • The HIMALAYA phase 3 trial aimed to assess outcomes in patients with cardiovascular or metabolic CMs.
  • Patients with CMs benefited similarly from STRIDE, confirming its long-term efficacy and safety profile.

The 4-year HIMALAYA analysis revealed that STRIDE (Single T Regular Interval D) maintained an overall survival (OS) advantage over sorafenib (S) and showed further improvement in patients achieving disease control (Sangro et al., Ann Oncol 2024). Cardiovascular (CV) and metabolic (MB) comorbidities (CMs) are common in individuals with hepatocellular carcinoma (HCC) and can influence treatment options and outcomes.

Lorenza Rimassa and colleagues aimed to evaluate the outcomes of patients with CV or MB CMs in the HIMALAYA study.

Patients’ CMs were based on medical history at baseline and classified using preferred terms from CV or MB SMQs. Patients with multiple CMs were counted once. The study evaluated OS by CMs iin the full analysis set (FAS) of patients randomized to STRIDE, D, or S, including long-term survivors (LTS; alive ≥36 months post-randomization).

They estimated OS HRs and 95% CIs through unstratified Cox models. Safety was assessed in patients who received at least 1 dose of the study drug using the safety analysis set (SAS). The data cut-off was January 23, 2023.

The results showed that in FAS, hypertension (HT) was the most common CV CM (STRIDE, 212 [54%]; D, 163 [42%]; S, 197 [51%]) and type 2 diabetes (T2DM) was the most common MB CM (STRIDE, 141 [36%]; D, 104 [27%]; S, 110 [28%]).

In the Stride arm, OS HRs for patients with vs. without CMs were 0.86 (95% CI: 0.68-1.08) for CV and 1.16 (95% CI: 0.92-1.47) for MB. STRIDE showed higher 36—and 48-month OS rates compared to S in patients with CMs. Serious treatment-related adverse events (TRAEs) were similar for patients with CMs (21%) and all patients in the SAS (18%).

The study concluded that patients with CMs experienced similar OS benefits from STRIDE as those without, with no new safety signals observed. This supports STRIDE’s long-term benefits in a broad population with uHCC globally.

The trial was sponsored by AstraZeneca.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3

Clinical Trial: https://www.clinicaltrials.gov/study/NCT03298451

Rimassa L, Dayyani F, Kelley RK, et al. (2024). “Outcomes by comorbidities (CMs) with tremelimumab (T) and durvalumab (D) in the phase III HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).” Presented at ESMO GI 2024. (Abstract 169P)

TIS + CT Enhances OS & PD-L1 Status in Advanced ESCC

KEY TAKEAWAYS

  • The BGB-A317 phase 3 trial aimed to assess the eeficacy of TIS vs PBO + CT in pts with advanced ESCC.
  • The primary endpoint was OS.
  • Improved OS with TIS + CT in PD-L1 TAP ≥1%; TAP and CPS scores showed high concordance.

Tislelizumab (TIS) (an anti–PD-1 antibody) + chemotherapy (CT) demonstrated significant overall survival (OS) benefit vs placebo (PBO) + CT as first-line (1L) therapy for advanced esophageal squamous cell carcinoma (ESCC) in all randomized patients (pts; stratified HR 0.66) and pts with PD-L1 Tumor Area Positivity (TAP) score ≥10% (stratified HR 0.62). Sustained survival benefit was observed at 3 yrs follow-up.

Eric Raymond and the team reported exploratory analyses of OS by PD-L1 expression status and consesus of PD-L1 TAP and combined positive score (CPS).

Researchers performed an inclusive analysis of adults with advanced ESCC who were randomized (1:1) to IV TIS 200 mg or PBO every 3 weeks alongside investigator-chosen CT (platinum + fluoropyrimidine or platinum + paclitaxel) until disease progression or intolerable toxicity. The primary endpoint was OS. Tissue samples underwent staining using the VENTANA PD-L1 (SP263) assay. PD-L1 expression was initially assessed by tumor proportion score (TPS) and subsequently re-evaluated post hoc by CPS. OS was evaluated using various PD-L1 cutoffs, with investigation into the concordance between TPS and CPS at multiple cutoff points. Interclass correlation coefficient (ICC) and Cohen’s Kappa were calculated to assess agreement.

Results indicated that of 649 pts who were randomized in the study, PD-L1 status was evaluable in 542 pts for TAP and 537 pts for CPS. The distribution of PD-L1 TAP scores was as given here: 223 pts (34%) had a TAP score ≥10%, 135 pts (21%) had a score between 5 to <10%, 123 pts (19%) had a score between 1 to <5%, and 61 pts (9%) had a score <1%. Followed by a minimum follow-up period of 3 years, the analysis pinpointed that OS was significantly enhanced in TIS + CT vs PBO + CT in PD-L1 subgroups with TAP scores ≥1%. Whereas, the OS outcomes in the subgroup with TAP score <1% were limited due to corresponding sample size.

The OS results based on TAP and CPS scores reflected similar findings. The ICC between TAP and CPS was 0.85 (95% CI 0.80–0.88), which suggested a high degree of alignment between these two methods of assessing PD-L1 expression. Furthermore, TAP and CPS scores demonstrated substantial concordance in terms of overall percentage agreement and Cohen’s Kappa statistic, underscoring the consistency in their assessment of PD-L1 expression levels in the study population.

The findings concluded that TIS + CT as a promising first-line therapy for advanced ESCC. Concordance between TAP and CPS scoring methods affirms their reliability in assessing PD-L1 expression .

The trial was sponsored by BeiGene.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/34

Clinical Trial: https://clinicaltrials.gov/study/NCT03783442

Raymond E, Xu J, Kato K, et al. (2024). “Tislelizumab (TIS) + chemotherapy (CT) vs placebo (PBO) + CT in advanced or metastatic esophageal squamous cell carcinoma (ESCC): PD-L1 biomarker analysis from RATIONALE-306.” Presented at ESMO-GI 2024, (Abstract 395MO)

Efficacy of IBI343 in CLDN18.2-Positive G/GEJ AC

KEY TAKEAWAYS

  • The phase 2 trial aimed to evaluate IBI343, targeting CLDN18.2, in solid tumors, especially G/GEJ AC.
  • The endpoints were to determine safety and efficacy.
  • Researchers noticed favorable tolerability and promising efficacy of IBI343 in pts with CLDN18.2-positive G/GEJ AC.

CLDN18.2 is a promising target for solid tumors, particularly gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC). IBI343 comprises anti-CLDN18.2 monoclonal antibody conjugated to exatecan (topoisomerase I inhibitor).

Jia Jenny Liu and the team aimed to assess the efficacy and safety of IBI343 in patients (pts) with solid tumors, focusing on those with CLDN18.2-positive G/GEJ AC.

Researchers performed an inclusive analysis of eligible pts who had failed or were intolerant to standard therapy. Dose escalation of IBI343 was conducted at 0.3, 1, 3, 6, 8, and 10 mg/kg every 3 weeks. Selected dose levels were expanded in pts with G/GEJ AC showing ≥1% tumor cells with membranous CLDN18.2 expression (1+/2+/3+) by IHC. Safety and efficacy endpoints were assessed.

About 159 pts from China and Australia were enrolled as of January 15, 2024, with 79 pts receiving 6 mg/kg and 51 pts receiving 8 mg/kg of IBI343. Dose-limiting toxicities (DLTs) occurred in 2 out of 6 pts at 10 mg/kg. Treatment-emergent adverse events (TEAEs) affected 149 pts (93.7%), with severe (≥Grade (G) 3) TEAEs in 79 pts (49.7%).

The most common TEAEs included anemia (54.7%), decreased white blood cell count (47.8%), and decreased neutrophil count (46.4%). Severe gastrointestinal toxicities were infrequent, with vomiting, nausea, and decreased appetite each reported in less than 2% of pts. Hypoalbuminemia affected 24.5% of pts without severe cases. TEAEs led to treatment discontinuation in 1.3% of pts, with no treatment-related deaths reported.

As of March 29, 2024, efficacy was evaluated in 99 pts with any CLDN18.2 expression in G/GEJ AC, of whom 73.7% had received at least 2 prior lines of treatment and 82.0% had undergone prior immunotherapy. The overall objective response rate (ORR) was 32.3% (95% CI: 23.3-42.5), and the disease control rate (DCR) was 75.8% (95% CI: 66.1-83.8). Among pts with CLDN18.2 (2+/3+ ≥40%), ORR and DCR at 6 mg/kg were 37.5% (95% CI: 24.0-52.6) and 89.6% (95% CI: 77.3-96.5), respectively, and at 8 mg/kg (n=29) were 44.8% (95% CI: 26.4-64.3) and 82.8% (95% CI: 64.2-94.2), respectively.

The median progression-free survival (PFS) was 5.6 months (95% CI: 4.2-7.3) at 6 mg/kg and 5.5 months (95% CI: 4.2-NC) at 8 mg/kg. In pts with CLDN18.2 (2+/3+ ≥75%), ORR and DCR at 6 mg/kg were 46.7% (95% CI: 28.2-65.7) and 93.3% (95% CI: 77.9-99.2), respectively, and at 8 mg/kg were 52.9% (95% CI: 27.8-77.0) and 88.2% (95% CI: 63.6-98.5), respectively. Median PFS was 6.8 months (95% CI: 4.2-NC) at 6 mg/kg and 5.5 months (95% CI: 4.2-NC) at 8 mg/kg.

The study concluded that IBI343 demonstrated favorable tolerability in all pts and showed promising efficacy in CLDN18.2-positive G/GEJ AC.

The trial was sponsored by the Innovent Biologics (Suzhou) Co. Ltd.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/34

Clinical Trial: https://clinicaltrials.gov/study/NCT05458219

Jia Jenny Liu, Xianjun Yu, Jian Zhang, et al. (2024). “396MO – Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in pts (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study.” Presented at ESMO-GI 2024 (Abstract 396MO).

Mitazalimab + mFOLFIRINOX Shows Promise in mPDAC: OPTIMIZE-1

KEY TAKEAWAYS

  • The OPTIMIZE-1 phase 1 & 2 trial aimed to investigate the safety and efficacy of mitazalimab combined with mFOLFIRINOX in pts with mPDAC.
  • The primary endpoint was to determine ORR.
  • Researchers noticed significant efficacy in terms of survival benefit and immune activation; further investigation is ongoing.

With a 5-year overall survival (OS) rate <5%, systemic therapies for metastatic pancreatic ductal adenocarcinoma (mPDAC) are associated with poor outcomes.

Teresa Macarulla Mercade and the team aimed to assess the safety and efficacy of mitazalimab, a human CD40 agonistic IgG1 antibody, combined with mFFX in mPDAC patients (pts).

They performed an inclusive analysis in OPTIMIZE-1, an open-label, single-arm, multicenter, phase 1b/2 study. Newly diagnosed, chemotherapy-naïve pts with metastatic pancreatic ductal adenocarcinoma (mPDAC) received mitazalimab on day 1, followed by a 2-week dosing regimen starting with mFOLFIRINOX on day 8 and mitazalimab on day 10. Phase 1b established 900 μg/kg as the recommended phase 2 dose of mitazalimab. The phase 2 primary endpoint assessed overall response rate (ORR), with secondary endpoints including safety, duration of response (DoR), progression-free survival (PFS), and OS.

About 70 pts received either 450 μg/kg (n=5) or 900 μg/kg (n=65) of mitazalimab in combination with mFFX. Common treatment emergent adverse events (TEAEs) of Grade ≥3 included neutropenia (25.7%; 18 pts), hypokalemia (15.7%; 11 pts), anemia and thrombocytopenia (11.4%; 8 pts), consistent with the safety profile of mFFX. Four pts (5.7%) discontinued treatment due to TEAEs. Among the 57 evaluable pts treated with the 900 μg/kg dose of mitazalimab, the confirmed ORR was 40.4%, with 22 pts achieving partial responses and 1 patient achieving a complete response.

Additionally, 22 pts achieved stable disease, resulting in a disease control rate of 78.9%. The unconfirmed ORR was 50.9%. Median DoR was 12.5 months, median progression-free survival (mPFS) was 7.7 months (with a 6-month PFS of 62.4%), and median overall survival (mOS) was 14.3 months (with a 1-year OS of 59.3%). Increases in CD38+ NKT cells after the first mitazalimab infusion correlated significantly with the depth of response, with similar trends observed in CD38+ and Ki67+ CD8 T cell populations. Tumor mutational burden was not associated with any endpoints.

The study concluded that the OPTIMIZE-1 trial achieved its primary endpoint, demonstrating a manageable safety profile and promising DoR linked to significant survival benefits. The activation profile of NKT and T cells indicates a potential role for mitazalimab in fostering robust anti-tumor responses. These compelling findings support advancing to a randomized phase 3 study for further validation and clinical integration.

The trial was sponsored by the Alligator Bioscience AB.

Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/34

Clinical Trial: https://clinicaltrials.gov/study/NCT04888312

Mercade T.M., Borbath I, Geboes K, et al. (2024). “280MO – CD40 agonist mitazalimab combined with mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Primary analysis of the OPTIMIZE-1 phase Ib/II study.” Presented at ESMO-GI 2024 (Abstract 280MO).

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