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Kazuhiko Nakagawa
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MA15 - Colliding Approaches - EGFR and Immunotherapy (ID 916)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 13:30 - 15:00, Room 107
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MA15.03 - PD-L1 Expression in Untreated EGFRm Advanced NSCLC and Response to Osimertinib and SoC EGFR-TKIs in the FLAURA Trial (ID 12989)
13:40 - 13:45 | Author(s): Kazuhiko Nakagawa
- Abstract
- Presentation
Background
In the Phase III FLAURA trial (NCT02296125), osimertinib significantly improved PFS relative to SoC EGFR-TKIs (gefitinib/erlotinib) in patients with untreated Ex19del/L858R positive (EGFRm) NSCLC. EGFRm NSCLC tumors can exhibit high PD-L1 expression, an important biomarker for immunotherapy treatment decisions. The frequency and clinical relevance of exhibiting both biomarkers prior to treatment are unclear. We report PD-L1 expression in patients with EGFRm advanced NSCLC and association with clinical outcomes following EGFR-TKI treatment.
a9ded1e5ce5d75814730bb4caaf49419 Method
Tissue samples from 994 patients with advanced NSCLC were screened for EGFR Ex19del/L858R mutations for enrolment in FLAURA; 556 were randomized to treatment. 197 tissue-blocks from the screened population (including EGFR mutation-positive and -negative samples) were tested for PD-L1 using the SP263 (Ventana) immunohistochemical assay; positive tumour cell (TC) staining PD-L1 TC≥25% and TC≥1% thresholds were applied. PFS was investigator-assessed, per RECIST 1.1, according to PD-L1-expressers (TC≥1%) or -negatives (TC<1%) in randomized patients.
4c3880bb027f159e801041b1021e88e8 Result
193/197 blocks had sufficient tumor tissue for staining. 65/193 patients were EGFR mutation-negative. 128/193 patients were EGFR mutation-positive: 106/128 were randomized to treatment (osimertinib: 54; SoC: 52). The table presents PD-L1 expression according to EGFR mutation status. For PD-L1-expressers (TC≥1%), median PFS was 18.4 months for osimertinib and 6.9 months for SoC (HR 0.30 [95% CI 0.15, 0.60]). For PD-L1-negative patients (TC<1%), median PFS was 18.9 months for osimertinib and 10.9 months for SoC (HR 0.37 [95% CI 0.17, 0.74]).
8eea62084ca7e541d918e823422bd82e ConclusionPD-L1 TC≥1%, n (%)
PD-L1 TC≥25%, n (%)
EGFR mutation-negative (n=65)
Screened population (n=65)
44 (68)
23 (35)
EGFR mutation-positive (n=128)
Screened population (n=128)
65 (51)
10 (8)
Randomized to treatment (n=106)
52 (49)
8 (8)
Randomized to osimertinib (n=54)
28 (52)
3 (6)
Randomized to SoC EGFR-TKI (n=52)
24 (46)
5 (10)
There was PFS benefit with osimertinib versus SoC regardless of whether tumors were PD-L1-expressers (TC≥1%) or -negatives (TC<1%). Using the TC≥25% threshold, PD-L1 prevalence was lower in EGFR mutation-positive than mutation-negative samples; there were insufficient patients with TC≥25% tumors for PFS assessment.
These results support the efficacy of EGFR-TKIs, including osimertinib, as first-line treatment of EGFRm advanced NSCLC, irrespective of PD-L1 expression.
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MA26 - New Therapies and Emerging Data in ALK, EGFR and ROS1 (ID 930)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 201 BD
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MA26.11 - Effects of Dose Modifications on the Safety and Efficacy of Dacomitinib for EGFR Mutation-Positive NSCLC (ID 13318)
14:40 - 14:45 | Author(s): Kazuhiko Nakagawa
- Abstract
- Presentation
Background
In patients with EGFR mutation-positive advanced stage NSCLC, first-line dacomitinib significantly improved PFS, OS, DoR and time to treatment failure vs gefitinib (ARCHER 1050; NCT01774721).1,2 Dacomitinib starting dose was 45 mg QD for all patients, with reductions to 30 or 15 mg QD permitted. We explored effects of dacomitinib dose reduction on safety and efficacy in this ongoing study.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with newly diagnosed stage IIIB/IV or recurrent NSCLC harboring an EGFR mutation (exon 19 del or exon 21 L858R) randomized to dacomitinib received 45 mg PO QD. Study endpoints and protocol-defined dose reduction parameters were previously described.1 We evaluated reasons for dose reductions, and their effects on incidence and severity of common adverse events (AEs) and key efficacy endpoints (PFS, OS, ORR). Data cutoff dates: 17-Feb-2017 (OS), 29-Jul-2016 (other endpoints).
4c3880bb027f159e801041b1021e88e8 Result
Overall, 150 (66.1%) patients dose reduced for AEs (87 and 63 reduced to 30 and 15 mg QD as lowest dose, respectively); most commonly for skin toxicities (62.6%) and diarrhea (14.0%). Median time to each successive dose reduction was ~12 weeks. Incidence and severity of AEs declined following dose reduction, including grade ≥3 diarrhea (11.3% before vs 4.0% after), dermatitis acneiform (15.3% vs 6.7%), stomatitis (3.3% vs 2.7%) and paronychia (7.3% vs 4.7%).
PFS was similar in dose-reduced and all dacomitinib-treated patients (Figure).
Median OS results were also similar (dose-reduced patients: 36.7 mo [95% CI: 32.6, NR]; all dacomitinib-treated patients: 34.1 mo [95% CI: 29.5, 37.7] as were ORRs (dose-reduced patients: 79.3% [95% CI: 72.0, 85.5]; all dacomitinib-treated patients: 74.9% [95% CI: 68.7, 80.4]).
8eea62084ca7e541d918e823422bd82e Conclusion
Efficacy was similar in the dose-reduced patients and the overall study population. Incidence/severity of dacomitinib-related AEs decreased with dose reduction, thereby allowing patients to continue treatment.
References:
Wu, et al. Lancet Oncol. 2017.
Mok, et al. J Clin Oncol. 2018.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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OA02 - Novel Therapies in ROS1, HER2 and EGFR (ID 893)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 10:30 - 12:00, Room 105
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OA02.07 - Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer (ID 13325)
11:35 - 11:45 | Author(s): Kazuhiko Nakagawa
- Abstract
- Presentation
Background
DS-8201a is a HER2-targeting antibody-drug conjugate with a novel peptide-based cleavable linker, a topoisomerase I inhibitor payload, and a high drug-to-antibody ratio (7 to 8). In preclinical studies, DS-8201a showed broad antitumor activity, in a wide range of tumors. The ongoing phase 1 trial has a dose-escalation (part 1) and -expansion (part 2) and includes subjects with advanced breast cancer, gastric cancer, and other HER2-expressing/-mutated solid tumors. Here, we present updated results for subjects with HER2-expressing or -mutated non-small cell lung cancer (NSCLC).
a9ded1e5ce5d75814730bb4caaf49419 Method
Subjects with HER2-expressing (defined as IHC ≥1+ or amplified) or –mutated (detected by NGS or other platforms) NSCLC were eligible to enroll. HER2 expression and mutation were assessed using archival tissue. Adverse events (AEs), objective response rate (ORR), disease control rate (DCR: CR + PR + SD), and duration of response (DOR) were assessed.
4c3880bb027f159e801041b1021e88e8 Result
[Results will be updated for presentation at meeting] As of Apr 18, 2018, 12 subjects with HER2-expressing and/or -mutated NSCLC received ≥1 dose of DS-8201a at 6.4 mg/kg. Median age was 58.5 y with median of 3 prior regimens. At data cutoff, 8 of 12 (66.7%) subjects remain on treatment. HER2 IHC status was available for 7 subjects. Median duration of treatment was 3.66 months (range 0.69, 14.19). Eight of 10 (80.0%) subjects with ≥1 post-baseline scan (ps) experienced tumor shrinkage (100.0% of them at 1st ps at 6 weeks). Overall, confirmed ORR and DCR in the evaluable subjects was 5 of 8 (62.5%) and 6 of 8 (75.0%), respectively. Among subjects with HER2 IHC 2+ or IHC 3+ expression, 2 of 5 (40.0%) had a PR. Overall, median DOR was 11.5 months (range 0.03+, 11.53). Three of 12 (25.0%) subjects experienced a grade ≥3 AE. Common AEs included decreased appetite 66.7% (0.0% grade ≥3), nausea 58.3% (0.0% grade ≥3), alopecia 41.7% (0.0% grade ≥3), and fatigue 41.7% (0.0% grade ≥3). One fatal case of interstitial lung disease was reported in this subgroup.
8eea62084ca7e541d918e823422bd82e Conclusion
DS-8201a demonstrated promising antitumor activity in heavily pretreated NSCLC subjects.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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OA08 - Mesothelioma: Immunotherapy and microRNA for Diagnosis and Treatment (ID 907)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Mesothelioma
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 15:15 - 16:45, Room 201 BD
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OA08.01 - Long-Term Efficacy and Safety of Nivolumab in Second- or Third-Line Japanese Malignant Pleural Mesothelioma Patients (Phase II: MERIT Study) (ID 11833)
15:15 - 15:25 | Author(s): Kazuhiko Nakagawa
- Abstract
- Presentation
Background
Malignant Pleural Mesothelioma (MPM) is a rare and highly aggressive malignancy with poor prognosis and no treatment is approved for patients (pts) progressing after 1st line pemetrexed-platinum doublet. Here, we report latest analysis of MERIT study in previously treated Japanese MPM pts to update the previous report (WCLC 2017, Goto Y, et al).
a9ded1e5ce5d75814730bb4caaf49419 Method
This open-label study enrolled advanced or metastatic MPM pts previously treated with up to two regimens of chemotherapy including pemetrexed-platinum doublet. Enrollment criteria also included histologically-confirmed, unresectable MPM without prior surgery, measurable lesion and ECOG performance status 0-1. There was no restriction of PD-L1 status. Pts received Nivolumab 240 mg flat dose Q2W until progression or unacceptable toxicity. Primary endpoint was objective response rate (ORR) (modified RECIST by independent review committee, expected response rate was 19.2%); secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety.
4c3880bb027f159e801041b1021e88e8 Result
Thirty-four pts received Nivolumab in this study. Males: 85.2%, median age: 68.0 years (range 43-78), PS 1: 61.8%, epithelial/sarcomatoid/biphasic: 79.4%/8.8%/11.8%, 1 prior regimen: 70.6% and PD-L1 (≧1%)/PD-L1 (<1%)/not evaluable: 58.8%/35.3%/5.9%. At a median follow-up of 16.8 months (range: 1.8-20.2), ORR was 29.4 % (n=10, 95%CI: 16.8-46.2). DCR was 67.6% (n=23, 95%CI: 50.8-80.9). Median DOR was 11.1 months (95%CI: 3.5-16.2). Median PFS was 6.1 months (95%CI: 2.9-9.9) in all pts, 7.2 months (2.8-15.0) in PD-L1 (≧1%) and 2.9 months (1.4-9.3) in PD-L1 (<1%). Median OS was 17.3 months (95%CI: 11.5-NR) in all pts, 17.3 months (8.2-NR) in PD-L1 (≧1%), 11.6 months (5.8-NR) in PD-L1 (<1%), across tissue types, 15.7 months (95%CI: 8.0-NR) in epithelioid and not reached in sarcomatoid/biphasic pts. Six- and 12-month survival rates were 85.3% (95%CI: 68.2-93.6) and 58.8% (95%CI: 40.6-73.2). Twenty-six (76.5%) pts experienced treatment-related adverse event (TRAE), and 11 (32.4%) experienced grade 3/4 TRAEs. Most commonly reported TRAEs were skin disorder (n=6, 17.6%), elevated lipase (n=5, 14.7%), elevated amylase and diarrhea (n=4, 11.8%). Four pts required dose discontinuation because of interstitial pneumonia (n=2, grade2 and 3) and pneumonitis (n=2, grade3).
8eea62084ca7e541d918e823422bd82e Conclusion
Nivolumab shows durable long term efficacy and manageable safety profile in Japanese 2nd/3rd line MPM pts.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-34 - Docetaxel Plus Ramucirumab with Prophylactic PEG-G-CSF Support for Chemo-NaïVe Elderly NSCLC Patients: A Phase II Study (WJOG9416L) (ID 12400)
16:45 - 18:00 | Author(s): Kazuhiko Nakagawa
- Abstract
Background
Docetaxel monotherapy is the standard of care for chemo-naïve Japanese elderly patients with advanced non-small cell lung cancer (NSCLC), according to our results of phase III trial comparing docetaxel and vinorelbine monotherapies (WJTOG9904). In a pivotal phase III study (REVEL), docetaxel plus ramucirumab demonstrated superior response rate (RR) and progression-free survival (PFS) over docetaxel monotherapy in second-line setting for advanced NSCLC. These differences in RR and PFS were translated into overall survival (OS) benefit. This evidence prompted us to investigate docetaxel plus ramucirumab for chemo-naïve elderly patients. However, in a similarly designed Japanese randomized phase II trial (JVCG trial), febrile neutropenia (FN) was observed in 34.2% of docetaxel plus ramucirumab arm. This high incidence of FN is a clinical concern when using docetaxel plus ramucirumab for elderly patients. The ASCO practice guideline recommends primary prophylactic granulocyte-colony stimulating factor (G-CSF) when the risk of FN is 20% or higher. PEGylated-G-CSF (pegfilgrastim) administered once a cycle demonstrated reduction of FN incidence in many types of cancers. Based on the above background, we considered that primary prophylactic PEG-G-CSF would be beneficial for elderly NSCLC patients who received docetaxel plus ramucirumab.
a9ded1e5ce5d75814730bb4caaf49419 Method
This is a prospective multicenter, single-arm, phase II study conducted by West Japan Oncology Group (WJOG). Main inclusion criteria includes: chemo-naïve; aged ≥75; histologically or cytologically confirmed NSCLC; ECOG PS 0/1; adequate organ functions; with measurable disease; without contraindication of ramucirumab; written informed consent; and estimated life expectancy of at least 3 months. Intravenous docetaxel (60 mg/m2, day 1) plus ramucirumab (10 mg/kg, day 1) with subcutaneous PEG-G-CSF (3.6 mg, day 2) every 3 weeks is administered until progression. Continuous docetaxel or ramucirumab monotherapy is permitted when intolerable toxicities occur but clinical benefit is obtained by each drug. The primary endpoint is objective response rate (ORR). Secondary endpoints are PFS, OS, disease control rate, and safety. We assumed that the threshold and expected ORR were 20% and 35%, respectively. Based on this, the number of patients was calculated to be 59 to provide a power of 80% with probability of one-sided type I error being 0.05. Taking ineligible patients into account, the sample size was set at 65. When the study results are promising, we plan to conduct a phase III trial to compare docetaxel plus ramucirumab with PEG-G-CSF support vs. docetaxel monotherapy for chemo-naïve elderly NSCLC patients. Clinical trial information: UMIN000030598.
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable
8eea62084ca7e541d918e823422bd82e Conclusion
6f8b794f3246b0c1e1780bb4d4d5dc53
Section not applicable
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P1.14 - Thymoma/Other Thoracic Malignancies (Not CME Accredited Session) (ID 946)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.14-03 - Phase II Trial of Amrubicin and Cisplatin Chemotherapy for Invasive Thymoma: WJOG5509L (ID 11706)
16:45 - 18:00 | Author(s): Kazuhiko Nakagawa
- Abstract
Background
Background: Platinum and anthracycline combination chemotherapy has been considered as the standard treatment for invasive thymoma for a long time. The clinical activity of amrubicin (AMR)—an anthracycline agent—has been previously reported in the treatment of small cell lung cancer (SCLC). The aim of this study was to evaluate the efficacy and safety of the combination of AMR and cisplatin (CDDP) in patients with advanced or recurrent invasive thymoma.
a9ded1e5ce5d75814730bb4caaf49419 Method
Methods: Patients were eligible for inclusion in the study if they met the following criteria: were chemo-naive; not amenable to curative surgery or radiotherapy; and presented with histologically confirmed invasive thymoma in each site. The patients received AMR (35 mg/m2, on days 1–3) and CDDP (60 mg/m2, on day 1) every 3 weeks, for up to 4 cycles. The primary endpoint was the objective response rate (ORR) assessed by an independent review, and the secondary endpoints were overall survival (OS) and toxicity profile of the patients. Based on the SWOG 2-stage design, the planned sample size of 40 patients was determined to reject the ORR of 60% under the expectation of 80% with a power of 0.85 and a type I error of 0.05. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000003933.
4c3880bb027f159e801041b1021e88e8 Result
Results: From August 2010 to November 2014, a total of 26 patients were enrolled at 14 institutions in Japan. During the planned interim analysis in April 2014, the ORR of the 20 patients who had been enrolled so far, was assessed via independent review and found to be 55.6% (11/20), resulting in the early termination of this study because of its futility. In the final assessment, the ORR was 54.2% (95% confidence interval, 32.8–74.4) and the disease control rate was 95.8%. The OS did not reach the median value. The major grade 3 or 4 toxicities noted were neutropenia (96.2%), anemia (26.9%), anorexia (11.5%) and febrile neutropenia (26.9%), albeit these were transient and manageable. There was one treatment-related death.
8eea62084ca7e541d918e823422bd82e Conclusion
Conclusions: The combination of AMR with CDDP had minimal activity on invasive thymoma. Thus, we do not recommend further study of this regimen.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-75 - RELAY+, an Exploratory Study of Gefitinib with Ramucirumab in Untreated Patients with EGFR Mutation-Positive Metastatic NSCLC (ID 12637)
12:00 - 13:30 | Author(s): Kazuhiko Nakagawa
- Abstract
Background
RELAY is a randomized, double-blind phase 1b/3 study investigating the efficacy and safety of the addition of ramucirumab (a human IgG1 monoclonal antibody that binds to Vascular Endothelial Growth Factor (VEGF) Receptor 2) to erlotinib (an EGFR TKI) in treatment-naïve EGFR-mutant metastatic NSCLC. Results from the Phase 1b cohort showed that combining ramucirumab with erlotinib was safe with encouraging clinical activity and a median PFS of 17.1mo (Reck et al., Clinical Lung Cancer 2017). While enrolment for the RELAY Phase 3 cohort has been completed, the RELAY+ cohort was recently added to explore the safety and efficacy of the combination of ramucirumab with gefitinib, a frequently used EGFR TKI in East Asia.
a9ded1e5ce5d75814730bb4caaf49419 Method
RELAY+ is an open-label, 2-period, single-arm exploration of the efficacy and safety of the addition of ramucirumab to gefitinib in previously untreated East-Asian patients with EGFR mutation-positive metastatic NSCLC (Period 1) and of ramucirumab to osimertinib in patients whose disease progressed in Period 1 and harbors the T790M mutation (Period 2). The trial is planned to be conducted in Japan, Taiwan and South-Korea and is currently open for enrollment. Approximately 80 patients will be enrolled.
In Period 1 patients will receive ramucirumab (10mg/kg) every two weeks and gefitinib (250mg/day) until disease progression, unacceptable toxicity or other withdrawal criteria are met. The study objectives are to determine the 1-yr PFS rate, safety and patient reported outcomes (Lung Cancer Symptom Scale and EQ-5D-5L]). In Period 2 the efficacy and safety of ramucirumab (10mg/kg) every two weeks with osimertinib (80mg/day) will be explored.
Both RELAY+ and RELAY participants will be enrolled in a liquid biopsy exploratory substudy. ctDNA (circulating tumor DNA) from plasma samples will be used for ddPCR (droplet digital PCR) and NGS (Next Generation Sequencing) to characterize mechanisms of acquired resistance and to test the hypothesis if the addition of ramucirumab to an EGFR TKI delays or modifies the emergence of EGFR TKI resistance.
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable
8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable
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P3.01-96 - Clinical Characteristics of Non–Small Cell Lung Cancer Harboring Mutations in Exon 20 Of EGFR or HER2 (ID 11715)
12:00 - 13:30 | Author(s): Kazuhiko Nakagawa
- Abstract
Background
Unlike common epidermal growth factor receptor gene (EGFR) mutations that confer sensitivity to tyrosine kinase inhibitors (TKIs) in non–small cell lung cancer (NSCLC), mutations in exon 20 of either EGFR or the human EGFR2 gene (HER2) are associated with insensitivity to EGFR-TKIs, with treatment options for patients with such mutations being limited.
a9ded1e5ce5d75814730bb4caaf49419 Method
Clinical characteristics, outcome of EGFR-TKI or nivolumab treatment, and the presence of coexisting mutations were reviewed for NSCLC patients with exon-20 mutations of EGFR or HER2 as detected by routine application of an amplicon-based next-generation sequencing panel.
4c3880bb027f159e801041b1021e88e8 Result
Between July 2013 and June 2017, 206 patients with pathologically confirmed lung cancer were screened for genetic alterations including HER2 and EGFR mutations. Ten patients harbored HER2 exon-20 insertions (one of whom also carried an exon-19 deletion of EGFR), and 12 patients harbored EGFR exon-20 mutations. Five of the 13 patients with EGFR mutations were treated with EGFR-TKIs, two of whom manifested a partial response, two stable disease, and one progressive disease. Among the seven patients treated with nivolumab, one patient manifested a partial response, three stable disease, and three progressive disease, with most (86%) of these patients discontinuing treatment as a result of disease progression within 4 months. The H1047R mutation of PIK3CA detected in one patient was the only actionable mutation coexisting with the exon-20 mutations of EGFR or HER2.
8eea62084ca7e541d918e823422bd82e Conclusion
Potentially actionable mutations thus rarely coexist with exon-20 mutations of EGFR or HER2, and EGFR-TKIs and nivolumab show limited efficacy in patients with such exon-20 mutations.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.04-29 - Efficacy of Re-Treatment with Immune Checkpoint Inhibitors in Patients with Pretreated Advanced Non-Small Cell Lung Carcinoma (ID 13680)
12:00 - 13:30 | Author(s): Kazuhiko Nakagawa
- Abstract
Background
The majority of NSCLC patients treated with immune-checkpoint inhibitors (ICI) develop acquired resistance. Conventional cytotoxic chemotherapy remains the treatment of choice for those patients. There are case reports on re-administration of ICIs for advanced NSCLC; however, these case series are difficult to draw definitive conclusions. We therefore retrospectively reviewed the efficacy of retreatment with ICI in our hospital.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with pathologically confirmed advanced NSCLC who were treated with ICI in Kindai University hospital were retrospectively reviewed from December 2015 to July 2017. Among 212 NSCLC patients treated with ICIs, 10 patients (4.7 %) were retreated with ICI.
4c3880bb027f159e801041b1021e88e8 Result
Number of patients treated with Nivolumab, Pembrolizumab and Atezolizumab were four, five and one, respectively. The best response of initial treatment with ICIs among 10 patients were five partial response (PR), two stable disease (SD) and three progressive disease (PD). Whereas, three patients (30%) showed SD and the others (70%) had PD to ICI retreatment. No severe adverse events attributable to the ICIs were noted.
8eea62084ca7e541d918e823422bd82e Conclusion
In the limited number of retrospective study, we could not find good responders for retreatment with ICIs. Best overall response during the previous treatment period is not related to the efficacy of retreatment with ICIs. At present, former responder to ICI therapy may not be the proper candidate for ICI re-challenge treatment strategy. Further biomarker analysis and treatment strategy is warranted for the patients and physicians to retreat with ICIs.
6f8b794f3246b0c1e1780bb4d4d5dc53
