OA02.05 Sugemalimab vs Placebo after cCRT or sCRT in pts with Unresectable Stage III NSCLC: Final PFS Analysis of a Phase 3 Study

Wu, Yi‐Long; Zhou, Q.; Chen, M.; Pan, Y.; Jian, O.; Hu, D.; Lin, Q.; Wu, G.; Cui, J.; Chang, J.; Cheng, Y.; Huang, C.; Liu, A.; Yang, N.; Gong, Y.; Zhu, C.; Ma, Z.; Fang, J.; Chen, G.; Zhao, J.; Shi, A.; Lin, Y.; Li, G.; Liu, Y.; Wang, D.; Wu, R.; Xu, X.; Shi, J.; Liu, Z.; Wang, J.; Yang, J.

doi:10.1016/j.jtho.2022.07.021

Cited by 11 publications

(16 citation statements)

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“…The breakthrough of the PACIFIC trial not only set a new standard for treating unresectable LA‐NSCLC but also established a foundation for post‐CRT ICI consolidation therapy 4,6 . Echoing these findings, the GEMSTONE‐301 trial demonstrated a notable PFS extension with sugemalimab consolidation compared to placebo (10.5 vs. 6.2 months, p = 0.0012) 7 . While the concurrent CRT arm showed a median PFS of 15.7 months, surpassing the 8.1 months in the sequential CRT arm, this underscores the broader potential patient benefit from ICI.…”

Section: Discussionmentioning

confidence: 97%

“…4,6 Echoing these findings, the GEMSTONE-301 trial demonstrated a notable PFS extension with sugemalimab consolidation compared to placebo (10.5 vs. 6.2 months, p = 0.0012). 7 While the concurrent CRT arm showed a median PFS of †Included are events that were reported in at least 10% of the patients in either group. Grade 5 adverse events of any cause occurred in two patients who received neoadjuvant therapy; one died of immune-related pneumonitis during the induction phase, and another succumbed to RP following the completion of CRT.…”

Section: Discussionmentioning

confidence: 99%

“…Updated results from the PACIFIC trial demonstrated that the addition of the consolidation ICI after concurrent CRT significantly prolonged overall survival (OS) to 47.5 months, compared with 29.1 months in the placebo group 6 . The GEMSTONE‐301 trial further supported the benefit of ICI consolidation, indicating a marked improvement in progression‐free survival (PFS) after either concurrent or sequential CRT 7 . Unfortunately, despite these advances, nearly half of the patients with unresectable LA‐NSCLC are unable to receive consolidation ICI after concurrent CRT, which is associated with a dismal prognosis 8 …”

Section: Introductionmentioning

confidence: 99%

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Induction immunochemotherapy followed by definitive chemoradiotherapy for unresectable locally advanced non‐small cell lung cancer: a multi‐institutional retrospective cohort study

Wu,

Cheng,

Sun

et al. 2024

MedComm

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This study aimed to evaluate the efficacy and safety of induction immunochemotherapy followed by definitive chemoradiotherapy (CRT) for unresectable locally advanced non‐small cell lung cancer (LA‐NSCLC). We identified unresectable stage III NSCLC patients who received induction immunochemotherapy. Overall survival (OS) and progression‐free survival (PFS) were the primary endpoints. From February 2019 to August 2022, 158 patients were enrolled. Following the completion of induction immunochemotherapy, the objective response rate (ORR) and disease control rate (DCR) were 52.5% and 83.5%, respectively. The ORR of CRT was 73.5%, representing 68.4% of the total cohort. The median PFS was 17.8 months, and the median OS was 41.9 months, significantly higher than in patients who received CRT alone (p < 0.001). Patients with concurrent CRT demonstrated markedly improved PFS (p = 0.012) and OS (p = 0.017) than those undergoing sequential CRT. Additionally, those with a programmed‐death ligand 1 (PD‐L1) expression of 50% or higher showed significantly elevated ORRs (72.2% vs. 47.2%, p = 0.011) and superior OS (median 44.8 vs. 28.6 months, p = 0.004) compared to patients with PD‐L1 expression below 50%. Hematologic toxicities were the primary severe adverse events (grade ≥ 3) encountered, with no unforeseen treatment‐related toxicities. Thus, induction immunochemotherapy followed by definitive CRT demonstrated encouraging efficacy and tolerable toxicities for unresectable LA‐NSCLC.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Induction immunochemotherapy followed by definitive chemoradiotherapy for unresectable locally advanced non‐small cell lung cancer: a multi‐institutional retrospective cohort study

Wu,

Cheng,

Sun

et al. 2024

MedComm

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“…Based on these results, on June 6, 2022, sugemalimab was approved in China for the treatment of unresectable stage III NSCLC without progression after concurrent or sequential chemoradiotherapy. Subsequent results of Gemstone-301 showed median PFS times after sugemalimab and placebo treatment of 10.5 and 6.2 months (HR = 0.65), respectively, for both sequential and concurrent chemoradiotherapy; 8.1 and 4.1 months (HR = 0.57), respectively, for sequential chemoradiotherapy; and 15.7 and 8.3 months (HR = 0.71), respectively, for concurrent chemoradiotherapy [ 57 ]. The OS in the sugemalimab and placebo groups was inconclusive (not reached vs. 25.9 months) after median follow-up durations of 27.1 and 23.5 months, respectively.…”

Section: Localized Nsclcmentioning

confidence: 99%

Emerging evidence and treatment paradigm of non-small cell lung cancer

et al. 2023

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Research on biomarker-driven therapy and immune check-point blockade in non-small cell lung cancer (NSCLC) is rapidly evolving. The width and depth of clinical trials have also dramatically improved in an unprecedented speed. The personalized treatment paradigm evolved every year. In this review, we summarize the promising agents that have shifted the treatment paradigm for NSCLC patients across all stages, including targeted therapy and immunotherapy using checkpoint inhibitors. Based on recent evidence, we propose treatment algorithms for NSCLC and propose several unsolved clinical issues, which are being explored in ongoing clinical trials. The results of these trials are likely to impact future clinical practice.

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“…However, whether upfront chemoimmunotherapy before chemoradiotherapy (CRT) could bene t patients is unknown. Although consolidation immunotherapy could bene t patients with stage III NSCLC who received concurrent (cCRT) or even sequential chemoradiotherapy (sCRT), the survival bene t is signi cantly less for patients with sCRT than those with cCRT [4][5][6][7][8]. Induction treatment has the theoretical advantage of reducing the target volume to meet normal tissue constrains.…”

Section: Introductionmentioning

confidence: 99%

Induction chemoimmunotherapy may improve outcomes to chemoradiotherapy for unresectable stage III NSCLC patients

Song

Zhang

Ren

et al. 2023

Preprint

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Objective Currently, the value of induction chemoimmunotherapy before chemoradiotherapy (CRT) in unresectable stage III non-small cell lung cancer (NSCLC) has not been established. This study aimed to investigate the role of induction chemoimmunotherapy for unresectable stage III NSCLC. Patients and Methods Patients diagnosed with stage III NSCLC who received CRT at Tianjin Cancer Hospital between August 2014 and December 2021 were retrospectively analysed. Based on induction chemoimmunotherapy or not, patients were allocated to I-CRT group or CRT group. Clinical outcomes including progression-free survival (PFS) and overall survival (OS) were estimated. Results A total of 255 patients were included, with 51 (20.0%) in the I-CRT group and 204 (80.0%) in the CRT group. The median PFS was 24.8 months in the I-CRT group vs. 12.6 months in the CRT group (p = 0.004), and the median OS was not reached (NR) vs. 32.4 months (p = 0.040). The multivariate analysis showed that induction chemoimmunotherapy was the independent factor favoring PFS (HR = 0.497, p = 0.003) and OS (HR = 0.459, p = 0.038). No significant differences were found in adverse effects (p > 0.05). The objective response rate (ORR) after induction chemoimmunotherapy was significantly higher than that after induction chemotherapy (56.9% vs. 22.2%, p = 0.000). Patients with induction chemoimmunotherapy before concurrent chemoradiotherapy had prolonged PFS (median NR vs. 14.9 months, p = 0.012) and OS (median NR vs. 26.5 months, p = 0.074) compared to those with induction chemotherapy. Conclusion Induction chemoimmunotherapy may improve outcomes to CRT and is well tolerated for unresectable stage III NSCLC patients. Prospective randomized trials need to be performed to further validate these findings.

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OA02.05 Sugemalimab vs Placebo after cCRT or sCRT in pts with Unresectable Stage III NSCLC: Final PFS Analysis of a Phase 3 Study

Cited by 11 publications

References 0 publications

Induction immunochemotherapy followed by definitive chemoradiotherapy for unresectable locally advanced non‐small cell lung cancer: a multi‐institutional retrospective cohort study

Induction immunochemotherapy followed by definitive chemoradiotherapy for unresectable locally advanced non‐small cell lung cancer: a multi‐institutional retrospective cohort study

Emerging evidence and treatment paradigm of non-small cell lung cancer

Induction chemoimmunotherapy may improve outcomes to chemoradiotherapy for unresectable stage III NSCLC patients

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