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- bemarituzumab (AMG 552) / Amgen, Opdivo (nivolumab) / Ono Pharma, BMS
Phase Ib results of bemarituzumab (BEMA)+mfolfox6+nivolumab (NIVO) for advanced gastric/gastroesophageal junction cancer (G/GEJC): Fortitude-102 part 1 () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3014;
P1b
Conclusions This is the first time a combination of BEMA, mFOLFOX6, and NIVO is assessed. In part 1, consistent safety and PK profiles suggest no negative interaction, with no new safety signals after 6 mo.
- spartalizumab (PDR001) / Novartis
Perioperative treatment in resectable gastric cancer with spartalizumab combined with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): The GASPAR phase II trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3008;
P2
15 pts (23%) experienced post-surgery G3/4 complications. Conclusions Spartalizumab combined with FLOT shows high efficacy as perioperative tt in pts with resectable gastric or GEJ adenocarcinoma with a high rate of pathological complete regression and an acceptable safety profile.
- Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
Atezolizumab plus bevacizumab combined with transarterial chemoembolization and hepatic arterial infusion chemotherapy for unresectable hepatocellular carcinoma with high tumor burden () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2549;
Of the 32 (91.4%) pts who experienced treatment-related adverse events (AEs), 13 (37.1%) had grade 3-4 AEs, but no treatment-related deaths occurred. Table: 1005P Conclusions The results suggested that A+B combined with TACE-HAIC was a promising treatment option for uHTB-HCC pts, given its excellent therapeutic efficacy and manageable adverse events.
- Tevimbra (tislelizumab) / BeiGene
Efficacy and safety of tislelizumab combined with TKIs and FOLFOX4-HAIC in conversion therapy of unresectable hepatocellular carcinoma () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2546;
Methods Between April, 2021, and March, 2023, we retrospectively analyzed clinical data of patients with uHCC who underwent tislelizumab ,TKIs(Lenvatinib, Donafenib) and FOLFOX4-HAIC...All TRAES were tolerable and manageable. Conclusions Tislelizumab combined with TKIs and FOLFOX4-HAIC showed high conversion rate and acceptable toxicity in the treatment of uHCC, suggesting that this combination could be considered as a new conversion strategy in this population.
- Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Zepsun (donafenib) / Suzhou Zelgen
Donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab for unresectable hepatocellular carcinoma (uHCC): A prospective, single-arm phase II trial (DoHAICs study) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2543;
P2
Conclusions Combination treatment with donafenib and HAIC plus sintilimab showed promising clinical benefits and acceptable toxic effects in pts with uHCC. The enrollment and follow-up are continuing.
- Imfinzi (durvalumab) / AstraZeneca
Safety and efficacy of durvalumab plus hepatic artery infusion chemotherapy in HCC with severe portal vein tumor thrombosis (Vp3/4) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2528;
P2
The enrollment and follow-up are continuing. Background The HIMALAYA trial demonstrated that the efficacy of durvalumab (an PD-L1 inhibitor) is comparable to that of sorafenib in patients (pts) with advanced hepatocellular carcinoma (HCC), and its safety profile is more acceptable...Pts received HAIC of FOLFOX regimens (oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, fluorouracil 400 mg/m2, and fluorouracil 2,400 mg/m2) on day 1
- Focus V (anlotinib) / Advenchen, Sino Biopharm, benmelstobart (APL-502) / Apollomics
HAIC combined with anlotinib and TQB2450 as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after hepatectomy: A single-centre, non-randomised, open clinical study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2496;
P2
Safety profile indicated that 67 pts (98.5%) experienced treatment-related adverse events (TRAEs), and common grade 3 TRAEs included hypertension (8.8%), neutropenia (7.4%) and thrombocytopenia (5.9%). Conclusions HAIC combined with anlotinib and TQB2450 as adjuvant therapy for pts with HCC at high risk of recurrence after primary hepatectomy exhibits promising prognosis and tolerable safety profile, and further follow-up is needed for this study to obtain mature data.
- Avastin (bevacizumab) / Roche
REWENEC: REal-World Evidence in NEC provides a reliable external control arm to avoid randomization for second-line clinical trials - A post hoc proof of concept analysis with the randomized phase II BEVANEC study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2301;
P2
Conclusions HAIC combined with anlotinib and TQB2450 as adjuvant therapy for pts with HCC at high risk of recurrence after primary hepatectomy exhibits promising prognosis and tolerable safety profile, and further follow-up is needed for this study to obtain mature data. After first-line platinum
- Avastin (bevacizumab) / Roche, ompenaclid (RGX-202) / Inspirna
Phase Ib/II study of ompenaclid (RGX-202-01), afirst-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2230;
P1
Eligible pts had disease progression after a 1L oxaliplatin-containing regimen...There is a high unmet need for a safe and combinable oral pan-RASm therapy in mCRC. Recruitment of RASm pts continues and a randomized controlled trial in 2L RASm mCRC is planned.
- Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
A phase Ib dose escalation study of binimetinib plus mFOLFIRI in patients with metastatic RAS mutated colorectal cancer () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2229;
P1b
Methods Eligibility criteria: Pts >18 years with RAS mt mCRC, ECOG 0-1, acceptable organ function, measurable disease, and progression or ineligibility to oxaliplatin...The median PFS was 3.35 months (95% CI 2-8.61) and the median OS was 8.41 months (95% CI 4.7-12.8). Conclusions MEKi plus mFOLFIRI has acceptable toxicity and showed activity even in patients with prior progression on irinotecan.
- Enweida (envafolimab) / 3DMed, Alphamab, Tracon Pharma, Ascletis, suvemcitug (APX003) / Simcere, Mabwell (Shanghai) Biosci, Pyxis Oncology
Combination therapy of envafolimab, suvemcitug, and FOLFIRI in patients with metastatic microsatellite stable (MSS) or mismatch-repair proficient (pMMR) colorectal cancer: Results from a phase II clinical trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2220;
P2
Eligible pts had received at least one prior line of treatment for MSS/pMMR mCRC and were treated with envafolimab plus suvemcitug and FOLFIRI (Irinotecan, Leucovorin, and 5-Fluorouracil)...Conclusions To the best of our knowledge, this is the first study demonstrated promising antitumor activity and a manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with MSS/ pMMR mCRC who had failed at least one line of therapy. The results support further evaluation of the therapy in a larger population.
- Opdivo (nivolumab) / Ono Pharma, BMS
Predictive value of C-reactive protein (CRP) in microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) patients given first-line alternating short-course oxaliplatin-based chemotherapy (FLOX) and nivolumab () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2216;
P2
Conclusions In MSS-mCRC patients receiving first-line therapy, CRP <5.0 mg/L after initial two FLOX cycles identified patients responding to sequential nivolumab with improved PFS compared to patients continuing FLOX. As a rapid, cost-effective analysis, and if early oxaliplatin-based chemotherapy counteracts tumour-associated systemic inflammation, CRP may predict ICB efficacy in MSS-mCRC.
- Vectibix (panitumumab) / Amgen, Takeda
Evaluation of the metastatic colorectal cancer score (mCCS) in predicting outcome for patients with RAS wild type metastatic colorectal cancer (mCRC) treated with first-line (1L) panitumumab (PAN) plus FOLFIRI/FOLFOX: Updated interim results of the non-interventional study VALIDATE () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2206;
P=N/A
mCCS predicting OS will be validated in the final analysis. No new safety signals emerged.
- Vectibix (panitumumab) / Amgen, Takeda
The systemic proteome of consensus molecular subtypes from patients with RAS wild-type metastatic colorectal cancer: Analysis from the randomized phase II PanaMa (AIO KRK0212) trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2205;
P2
In contrast to CMS2, CMS4 presented significant downregulation of peptidoglycan recognition protein 2 (PGLYRP2, 0.72-fold decrease; P=0.027) and upregulation of CRP (1.46-fold increase; P=0.027) and SERPINA1 (0.65-fold increase; P=0.048) and SERPINA3 (0.66-fold increase; P=0.048). Conclusions The identification of CMS-specific proteomic signatures helps elucidate the systemic setting of CMS-based tumor classification and ultimately may help inform the development of personalized treatment strategies for patients with mCRC.
- Elunate (fruquintinib) / Takeda
Updated results from the multicenter phase II study of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer (mCRC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2196;
P2
Conclusions Updated analysis of this study data further support current combination therapy with fruquintinib plus mFOLFOX6/FOLFIRI as the first-line therapy followed by fruquintinib plus capecitabine maintenance for advanced mCRC pts, which shows durable response and a favorable long-term safety profile. The study is still ongoing.
- Avastin (bevacizumab) / Roche
Predicting benefit from FOLFOXIRI plus bevacizumab versus FOLFOX/FOLFIRI plus bevacizumab in patients with metastatic colorectal cancer () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2194;
P2, P3
Conclusions Although our data suggest that patients with a low mortality risk have greater benefit of intensified treatment on an absolute scale, the predictions lack sufficient certainty to be used in clinical practice for individualised decision making. Larger samples are required to draw final conclusions on whether benefit from FOLFOXIRI could be predicted in patients with mCRC.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
The impact of surgical invasiveness on the efficacy of mFOLFOX6 in resected colorectal liver metastasis: An exploratory analysis of JCOG0603 () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2193;
Table: 609P Conclusions Surgical invasiveness, especially the relative resected liver weight, might affect both the tolerability and cytotoxic effect of mFOLFOX6. Adjuvant mFOLFOX6 should be cautiously administered when the extent of hepatectomy is large.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Resectability of colorectal liver metastases (CLM) with aflibercept plus FOLFIRI: Results from a prospective French cohort () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2192;
P2
All pts received a prior oxaliplatin-based regimen, 77.4% prior anti-VEGF and 19.0% prior anti-EGFR agents...Four pts (18.2%) had post-operative complications (all Dindo-Clavien grade I-II); 34.3% had grade ?3 adverse events with AFL+FOLFIRI, mainly general health deterioration (8.0%) and diarrhoea (3.6%). Table: 608P Secondary efficacy endpoints Conclusions This prospective cohort suggests that AFL+FOLFIRI allows a clinically relevant rate of conversion from potentially resectable/unresectable to resectable CLM.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Brazil-TNT: A randomized phase II trial of neo-adjuvant chemoradiation followed by FOLFIRINOX vs chemoradiation for stage II/III rectal cancer () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2186;
P3
After completing long-course 54Gy chemoradiation with capecitabine patients were randomized 1:1 to observation or 4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 135, 5-FU 2400)...Complete data from 96 patients will be presented at the meeting. This trial was supported by a grant from the Brazilian Ministry of Health (PROADI-SUS) - NUP 25000.164382/2020-81.
- 5-fluorouracil / Generic mfg.
Surgical quality for patients (pts) treated with neoadjuvant chemotherapy vs chemoradiation for locally advanced rectal cancer (LARC): PROSPECT (NCCTG N1048, alliance) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2181;
P2/3
Pts were randomized 1:1 to 5FUCRT with 5040 cGy over 5.5 weeks with capecitabine or 5FU (control) or 6 cycles of mFOLFOX6 (intervention) followed by restaging...Table: 597P Conclusions Low rate of positive radial margin along with high rate of complete/near complete TME and number of lymph nodes examined demonstrate a high quality of surgery in this multicenter trial. More pts treated with 5FUCRT (relative to the FOLFOX arm) required an ostomy and readmission within 30 days of surgery.
- Imfinzi (durvalumab) / AstraZeneca
The DUREC trial: Durvalumab plus total neoadjuvant therapy in locally advanced rectal cancer - a multicenter, single-arm, phase II study (GEMCAD-1703) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2179;
Pts received 6 cycles of FOLFOX with D at 1500 mg q4W, followed by CRT with capecitabine and D, continuing D until surgery...Mean number of administered cycles of mFOLFOX6 and durvalumab were 5.8 and 6.2, respectively, with 41 patients (67.2%) receiving 7 cycles of durvalumab before surgery...Conclusions The DUREC trial is the first prospective clinical study evaluating the combination of immunotherapy throughout the TNT process for treating MSS LARC. The study met its primary endpoint, demonstrating promising activity and safety, and deserving further development in a phase III study.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
The role of early change in circulating tumor DNA as a potential predictor of response to chemotherapy in patients with metastatic colorectal cancer () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2176;
P=N/A
6.27% group vs. MSAF change < 6.27% group: 317 days vs. 217 days; HR:1.598, 95%CI:1.016-2.514, P=0.03). Conclusions The early changes in ctDNA levels after initiation of first-line chemotherapy in mCRC would enable early prediction of response prior to radiological assessment.
- Tecentriq (atezolizumab) / Roche
Artificial intelligence-powered analysis of tumor lymphocytes infiltration: A translational analysis of AtezoTRIBE trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2155;
Background Adding atezolizumab (atezo) to FOLFOXIRI/bev prolongs PFS of mCRC patients (pts) in AtezoTRIBE trial...Conclusions IPs and IS by Lunit SCOPE IO provide a characterization of tumor microenvironment, being associated with Immunoscore, Immunoscore IC and TILs. Further development of AI-powered TILs analyses taking into account their densities may help identifying biomarkers of immunogenicity in mCRC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Artificial intelligence for detection of mismatch repair deficiency in colon carcinomas (alliance) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2153;
P3
Conclusions Among morphological tumor features quantified by AI, tumor immature desmoplastic stroma and TILs, particularly epithelial TIL densities, were best able to distinguish MMR-D from MMR-P tumors. These findings have implications for prognosis and subtype-based interventions and can guide spatial molecular interrogation.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Single cell AI-based detection of DNA mismatch repair deficiency in 1,988 colorectal cancers reveals prognostic and predictive value in the SCOT trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2152;
We applied it to over 2,000 cases from the SCOT clinical trial, which compared 3 vs 6 months of oxaliplatin-based adjuvant chemotherapy (mFOLFOX6 or CAPOX) for stage II/III CRC...Conclusions AIMMeR holds promise to reduce pathologist workflow and streamline clinical diagnostics in CRC. The possible predictive value of MMRd for chemotherapy regimen should be investigated in additional cohorts.
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
Individual patient data (IPD) meta-analysis of randomised trials to compare efficacy of second-line fluoropyrimidine-based chemotherapy in advanced biliary tract cancer (BTC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_1736;
P2
Conclusions Nal-IRI plus 5-FU/LV showed better survival outcomes when compared to mFOLFOX, mFOLFIRI, or 5-FU/LV alone. Nal-IRI plus 5-FU/LV may be a preferable second-line regimen for advanced BTC pts without targetable genetic alterations.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
The PEGASUS trial: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_1202;
P2
Conclusions LB may be used to guide the post-surgical clinical management of CC pts by reducing unnecessary toxicity and by improving the response to standard chemotherapy. Ongoing and newly designed randomized trials trials will define the clinical utility of LB for MRD in colon cancer.
- Avastin (bevacizumab) / Roche, Vectibix (panitumumab) / Amgen, Takeda
First-line systemic treatment in patients with initially unresectable colorectal cancer liver metastases (CRLM): Overall survival of the phase III CAIRO5 study of the Dutch Colorectal Cancer Group (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_1199;
P3
Recurrence within 6 months after complete local treatment occurred in 26 (49%) vs 29 (39%) patients in arm A vs B (p=0.28), and 28 (42%) vs 26 (39%) patients in arm C vs D (p=0.73). Conclusions In patients with initially unresectable CRLM, OS was not different between FOLFOXIRI-bevacizumab and FOLFOX/FOLFIRI-bevacizumab for right-sided and/or RAS/BRAFV600E mutated tumours, nor between adding panitumumab vs bevacizumab to FOLFOX/FOLFIRI for left-sided and RAS/BRAFV600E wild-type tumours.
- Vectibix (panitumumab) / Amgen, Takeda
FOxTROT: Results of embedded phase II evaluating the addition of panitumumab (pan) to neo-adjuvant FOLFOX for patients (pts) with KRAS-wt colon cancer (CC) with extended biomarker panel (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_1198;
No impact on tumour regression was seen with pan. Further testing and safety assessment is warranted.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Maintenance with 5FU/LV-Aflibercept after induction with FOLFIRI-Aflibercept vs FOLFIRI-Aflibercept until progression in older patients (pts) in 2nd line metastatic colorectal cancer (mCRC): The randomized AFEMA trial (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_882;
P2
Pts aged ?70 years who failed a prior oxaliplatin-based regimen, were randomly assigned (1:1) to induction with 6 cycles FOLFIRI-A followed by maintenance with 5FU/LV-A until progression (arm A, experimental) or FOLFIRI-A until progression (arm B, control)...In older pts, severe asthenia was significantly reduced with 5FU/LV-A maintenance. Table: 560MO Efficacy Arm A Experimental Arm B Control p-value FOLFIRI q2w + A 4 mg/kg IV 6 cycles 5FU/LV q2w + A 4mg/kg IV FOLFIRI q2w + A 4 mg/kg IV PFS (m), median (95%CI) 6.1 (5.3-6.9) 5.5 (4.8-6.2) 0.128a OS (m), median (95%CI) 12.2 (10.6-13.9) 11.5 (8.7-14.4) 0.466a ORR, % (95%CI) 20 (12.1-30.1) 9.4 (4.2-17.8) 0.082b aLog-rank bFisher test
- Keytruda (pembrolizumab) / Merck (MSD)
Pembrolizumab versus chemotherapy in microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC): 5-year follow-up of the randomized phase III KEYNOTE-177 study (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_877;
P3
Table: 560MO Efficacy Arm A Experimental Arm B Control p-value FOLFIRI q2w + A 4 mg/kg IV 6 cycles 5FU/LV q2w + A 4mg/kg IV FOLFIRI q2w + A 4 mg/kg IV PFS (m), median (95%CI) 6.1 (5.3-6.9) 5.5 (4.8-6.2) 0.128a OS (m), median (95%CI) 12.2 (10.6-13.9) 11.5 (8.7-14.4) 0.466a ORR, % (95%CI) 20 (12.1-30.1) 9.4 (4.2-17.8) 0.082b aLog-rank bFisher test Pts were randomly assigned 1:1 to receive pembro 200 mg Q3W or chemo (mFOLFOX6 or FOLFIRI Q2W
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
Modified (m)-FOLFOXIRI plus cetuximab treatment and predictive clinical factors for RAS/BRAF wild-type and left-sided metastatic colorectal cancer (mCRC): The DEEPER trial (JACCRO CC-13) (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_873;
P2
Background The DEEPER trial, which evaluated m-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, 5-FU 2400 mg/m2) plus cetuximab (cet) vs. bevacizumab (bev) as initial treatment in terms of depth of response (DpR) as the primary endpoint in RAS wild-type mCRC, has demonstrated a significantly better DpR of the cet arm (Tsuji A, et al...Conclusions m-FOLFOXIRI plus cet regimen could be a good option for upfront chemotherapy with high DpR and longer PFS in mCRC pts with RAS/BRAF wild-type and left-sided tumors. The benefit may be relevant for pts with extra-hepatic metastases or male.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
Cetuximab plus FOLFOXIRI versus cetuximab plus FOLFOX in RAS wild-type patients with initially unresectable colorectal liver metastases: The TRICE randomized clinical trial (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_872;
P2
Additionally, the triplet arm was associated with a higher incidence of grade 3-4 neutropenia (44.1% vs. 27.0%; P = .03) and diarrhea (5.9% vs. 0%; P = .03). Conclusions Although intensifying upfront systemic chemotherapy in RAS wild-type metastatic CRC patients offered a better depth of tumor response, there was an increase in neutropenia and diarrhea incidence with no significant difference in ORR, PFS, and R0 resection rate.
- Vectibix (panitumumab) / Amgen, Takeda
Panitumumab (P) + FOLFIRINOX or mFOLFOX6 in unresectable metastatic colorectal cancer (mCRC) patients (pts) with RAS/BRAF wild-type (WT) tumor status from circulating DNA (cirDNA): First results of the randomised phase II PANIRINOX-UCGI28 study (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_871;
P2
Table: LBA30 Arm A FOLFIRINOX+P (N=65) Arm B mFOLFOX6+P (N=27) Median follow-up (months) [95% CI] 32.0 [28.7; 32.3] 30.4 [23.4; 35.7] Complete response (number) (%) [95% CI] 5 7.7 [2.5; 17.0] 2 7.4 [0.9; 24.3] Objective response rate (complete + partial radiological reponse) 75.4% 77.8% Median PFS (months) [95% CI] 9.1 [8.1; 11.7] 9.0 [7.5; 13.2] Median OS (months) [95% CI] NR 20.4 [15.1; NR] Conclusions With 5 pts achieving CR in arm A and 95%CI including predetermined hypothesis in arm B, the study met its primary objective in str2. We confirm that genotyping tumors from cirDNA analysis is a relevant alternative to tissue before administrating anti-EGFR-based therapies in first line.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., docetaxel / Generic mfg.
5-fluorouracil and oxaliplatin with or without docetaxel in the first-line treatment of HER2 negative locally advanced (LA) unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma (GASTFOX-PRODIGE 51): A randomized phase III trial sponsored by the FFCD (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_744;
P3
Conclusions The addition of docetaxel to FOLFOX significantly improved PFS, OS and ORR in first-line treatment of advanced HER2 negative gastric or GEJ adenocarcinomas. mFLOT/TFOX can be considered as a new therapeutic option for patients eligible for a triplet regimen.
- Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Nab-paclitaxel plus gemcitabine versus modified FOLFIRINOX or S-IROX in metastatic or recurrent pancreatic cancer (JCOG1611, GENERATE): A multicentred, randomized, open-label, three-arm, phase II/III trial (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_740;
mFLOT/TFOX can be considered as a new therapeutic option for patients eligible for a triplet regimen. Patients were randomly assigned (1:1:1) to receive nab-paclitaxel (125 mg/m2) plus gemcitabine (1,000 mg/m2) on days 1, 8, 15, every 4 weeks, modified FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, l-leucovorin 200 mg/m2, and fluorouracil 2,400 mg/m2 on days 1
- Neoadjuvant chemotherapy with FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy for borderline resectable and resectable pancreatic cancer (PREOPANC-2): A multicenter randomized controlled trial (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_739;
SAE rates were 49% in the FFX arm and 43% in the CRT arm (p=0.26). Conclusions Neoadjuvant chemotherapy with FOLFIRINOX did not improve OS compared with neoadjuvant gemcitabine-based chemoradiotherapy in patients with borderline resectable and resectable PDAC.
- Imfinzi (durvalumab) / AstraZeneca
Pathological complete response (pCR) to durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric and gastroesophageal junction cancer (GC/GEJC): Interim results of the global, phase III MATTERHORN study (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_4;
P3
Conclusions The addition of D to perioperative FLOT therapy demonstrated a clinically meaningful and statistically significant improvement in pCR in resectable GC/GEJC, with a tolerable safety profile. The MATTERHORN study is ongoing for the primary endpoint of event-free survival.
- Keytruda (pembrolizumab) / Merck (MSD)
Pembrolizumab plus chemotherapy vs chemotherapy as neoadjuvant and adjuvant therapy in locally-advanced gastric and gastroesophageal junction cancer: The phase III KEYNOTE-585 study (Barcelona Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_3;
P3
Table: LBA74 Outcomes in main + FLOT cohort Efficacy Pembro + chemoN = 502 Pbo + chemoN = 505 Treatment difference (95% CI) Path CRa, % 13.0 (10.2-16.3) 2.4 (1.3-4.2) 10.6% (7.4-14.0) P<0.0001 Median EFS, mo (95% CI) 45.8 (35.9-NR) 25.7 (21.9-33.9) HR 0.81 (0.68-0.97) P=0.011 Median OS, mo (95% CI) 60.7 (51.5-NR) NR (45.7-NR) HR 0.93 (0.76-1.12) Safety Pembro + chemoN = 498 Pbo + chemoN = 503 NA Grade ? 3 drug-related AEs 67% 63% NA aIn first 987 pts randomized; HR, hazard ratio; NA, not applicable; NR, not reached Conclusions Neoadjuvant/adjuvant pembro + chemo followed by adjuvant pembro, significantly improved pathCR rate with no significant improvement in EFS vs placebo + chemo in pts with untreated, locally-advanced resectable G/GEJ cancer.
- | leucovorin calcium / Generic mfg., pemetrexed / Generic mfg.
Journal: Folinic Acid to Prevent Pemetrexed-Associated Neutropenia After Intrathecal Administration: A Quick Win. (Pubmed Central) - Jul 26, 2023
3 drug-related AEs 67% 63% NA aIn first 987 pts randomized; HR, hazard ratio; NA, not applicable; NR, not reached Conclusions Neoadjuvant/adjuvant pembro + chemo followed by adjuvant pembro, significantly improved pathCR rate with no significant improvement in EFS vs placebo + chemo in pts with untreated, locally-advanced resectable G/GEJ cancer. No abstract available
- || zolbetuximab (IMAB362) / Astellas
P2 data, Journal, Metastases: ILUSTRO: Phase 2 Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma. (Pubmed Central) - Jul 25, 2023
These data support the first-line development of zolbetuximab in patients whose tumors are CLDN18.2 positive. Across cohorts, zolbetuximab treatment was tolerable with no new safety signals.
- ||| Metastases: Out in @CCR_AACR. Interested in more data that supported GLOW and SPOTLIGHT, and ongoing FOLFOX + Zolbe + Nivo? @mdmanishshah @sara_lonardi1 @KoheiShitara @ILSONDavid ILUSTRO: Phase 2 Multicohort of Zolbetuximab in Advanced Claudin18.2+ GC/GEJ https://t.co/9FyuoHiRWk (Twitter) - Jul 25, 2023
- ||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Clinical, Metastases: https://t.co/a006obG9J7 Our outcomes from medical oncology @OffCMCVellore for patients with locally advanced rectal cancer. TNT protocol FOLFOX 12 wks-> LCCRT with full dose 5FU/LV -> TME. study by @ajoyojohn and protocol conceived & led by @todrashish, @ajoel_84 @divyathumaty https://t.co/Jy2W2stFMG (Twitter) - Jul 25, 2023
- BMF-219 / Biomea Fusion
COVALENT-102: A Phase 1/1b Study of BMF-219, A Menin Inhibitor in Patients with Unresectable, Metastatic NSCLC, PDAC, and CRC (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2329;
Subsequently, each indication will enroll independently patients in parallel expansion cohorts to obtain further safety and efficacy data.Eligible patients include those with any KRAS mutation and stage IIIB/IV NSCLC with 2-4 prior lines of therapy including checkpoint inhibitors (CPI) and/or platinum-based chemo bevacizumab; stage III/IV PDAC with 1 prior line of therapy including either FOLFIRINOX or gemcitabine/nab-paclitaxel ( platinum-based chemo); or stage III/IV CRC with 1 prior line of therapy including FOLFOX or FOLFIRI bevacizumab (prior ICI if MSI-H/dMMR)...Secondary objectives include further evaluation of safety and tolerability, characterization of the pharmacodynamics and pharmacokinetics of BMF-219, and efficacy based on the duration of response (DOR) & disease control rate (DCR). Assessment of progression-free survival (PFS), overall survival (OS) & time to response (TTR) are part of the exploratory endpoints.
- ||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Clinical, Heterogeneity, Metastases: "Locally advanced" rectal cancer is heterogeneous. PROSPECT mostly falls in the "favorable risk" subset of studies. This is supported by inclusion, enrolled pts, and path outcomes. Unprecedented pCR in FOLFOX arm also supports initial low-disease burden. (Twitter) - Jul 25, 2023
- | leucovorin calcium / Generic mfg., trimethoprim/sulfamethoxazole / Generic mfg., pyrimethamine / Generic mfg.
Journal: Unspecific congenital toxoplasmosis in a two-month-old baby. (Pubmed Central) - Jul 24, 2023
At 2 years, there signs of normal motoric, eye, and hearing development with underdeveloped kidneys. Therefore, pre-pregnancy counseling and education aimed at preventing toxoplasmosis during pregnancy should be increased and conducted routinely by health workers or trained cadres to reduce the risk of fetal defects.
- | methotrexate / Generic mfg.
Journal: The actions of methotrexate on endothelial cells are dependent on the shear stress-induced regulation of one carbon metabolism. (Pubmed Central) - Jul 21, 2023
The impact of shear stress on OCM suggested that MTX does not directly modulate endothelial function. The cardioprotective actions of MTX likely reflect direct actions on inflammatory cells and indirect benefit on the vascular endothelium.
- || 5-fluorouracil / Generic mfg.
Clinical, Journal, Metastases: Minimum and Optimal CA19-9 Response After Two Months Induction Chemotherapy in Patients with Locally Advanced Pancreatic Cancer: A Nationwide Multicenter Study. (Pubmed Central) - Jul 21, 2023
Furthermore, ?40% is the minimum cut-off demonstrating survival benefit. These cut-offs may be used when discussing treatment strategies during early response evaluation.
- | 5-fluorouracil / Generic mfg.
Journal: Preoperative chemotherapy prior to primary tumour resection for asymptomatic synchronous unresectable colorectal liver-limited metastases: The RECUT multicenter randomised controlled trial. (Pubmed Central) - Jul 20, 2023
These cut-offs may be used when discussing treatment strategies during early response evaluation. For asymptomatic synchronous unresectable CRLMs, Pre-PTR chemotherapy improved the PFS compared with upfront PTR.
- | thioguanine / Generic mfg., azacitidine / Generic mfg.
Trial completion date: AALL15P1: Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (clinicaltrials.gov) - Jul 20, 2023
P2, N=78, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
For asymptomatic synchronous unresectable CRLMs, Pre-PTR chemotherapy improved the PFS compared with upfront PTR. Trial completion date: Jun 2023 --> Jun 2024