healthbook WCGIC® 2018 Newsroom

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Expert Interview

Video published with permission from
Dr Alexander Siebenhüner

 

Personal Highlights from Dr Alexander Siebenhüner
Dr Siebenhüner shared his personal highlights from the WCGIC 2018.

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Study Highlights
  Metastatic Colorectal Cancer
Oral: Final Results and Translational Analyses from the CRICKET Study
The CRICKET study is the first prospective study that demonstrated rechallenge activity of cetuximab plus irinotecan in third-line patients with metastatic colorectal cancer, who had no RAS/BRAF mutations in pre-treatment liquid biopsies.

Reference: Rossini et al. O-007: Liquid biopsy allows predicting benefit from rechallenge with cetuximab(cet)+irinotecan(iri) in RAS/BRAF wild-type mCRC patients(pts) with resistance to 1st-line cet+iri: Final results and translational analyses of the CRICKET study by GONO, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.006, https://doi.org/10.1093/annonc/mdy149.006

  Metastatic Gastric Cancer
Late-Breaking Abstract: Results from the Phase III TAGS Study
In this global phase III TAGS study, trifluridine/tipiracil (FTD/TPI) plus best supportive care in patients with heavily pretreated metastatic gastric cancer (mGC) resulted in a significant overall survival (OS) and progression-free survival (PFS) benefit compared with placebo plus best supportive care. Median OS at data cut-off: 5.7 months in the FTD/TPI group vs 3.6 months in the placebo group (HR: 0.69 [95% CI: 0.56–0.85]; one-sided p=0.0003).
Median PFS: 2 months in the FTD/TPI group vs 1.8 months in the placebo group (HR: 0.57 [95% CI: 0.47–0.70]; two-sided p <0.0001).

Reference: Tabernero et al. LBA-002: Overall survival results from a phase III trial of trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard therapies (TAGS), Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy208.001, https://doi.org/10.1093/annonc/mdy208.001

Non-Resectable, Avanced or Metastatic Esophageal Squamous Cell Cancer
Oral: Phase III AIO/EORTC Trial
In this phase III trial, first-line cisplatin/5-fluorouracil plus panitumumab versus cisplatin/5-fluorouracil alone did not demonstrate an overall survival (OS) or progression-free survival (PFS) benefit in patients with non-resectable, advanced or metastatic esophageal squamous cell cancer.
Median PFS: 5.8 months for cisplatin/5-fluorouracil vs 5.3 months for cisplatin/5-fluorouracil plus panitumumab (HR: 1.21 [95% CI: 0.85–1.73]; p=0.29). Median OS: 10.3 months for cisplatin/5-fluorouracil vs 9.6 months for cisplatin/5-fluorouracil plus panitumumab (HR: 1.17 [95% CI: 0.79–1.75]; p=0.43).

Reference: Moehler et al. O-010: Cisplatin/5-fluorouracil +/- panitumumab for patients with non-resectable, advanced or metastatic esophageal squamous cell cancer: A randomized phase III AIO/EORTC trial with an extensive biomarker program, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.009, https://doi.org/10.1093/annonc/mdy149.009

 

  Metastatic Colorectal Cancer
Oral: Primary Analysis of the Phase II TASCO1 Study
The primary analysis of the TASCO1 phase II study demonstrates a promising activity of trifluridine/tipiracil plus bevacizumab in treatment-naïve patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for standard first-line therapy. Median progression-free survival (PFS): 9.2 months in the trifluridine/tipiracil plus bevacizumab group and 7.8 months in the capecitabine plus bevacizumab group.

Reference: Lesniewski-Kmak et al. O-022: Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): Results of the primary analysis, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.021, https://doi.org/10.1093/annonc/mdy149.021

 

  Advanced Hepatocellular Carcinoma
Late-Breaking Abstract: Pooled Analysis of the Phase III trials REACH and REACH-2
A pooled analysis of the two phase III trials REACH and REACH-2 showed a significant clinically meaningful benefit and a favorable safety profile with ramucirumab versus placebo in patients with advanced hepatocellular carcinoma (HCC) with baseline alpha-fetoprotein (AFP) ≥400 ng/mL following first-line sorafenib. Median overall survival (OS): 8.1 months for ramucirumab vs 5.0 months for placebo (HR: 0.694 [95% CI: 0.571–0.842]; p=0.0002).
Median progression-free survival (PFS): 2.8 months for ramucirumab vs 1.5 months for placebo (HR: 0.572 [95% CI: 0.472–0.694]; p<0.0001).

Reference: Zhu et al. LBA-001: Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: Pooled efficacy and safety across two global randomized Phase 3 studies (REACH-2 and REACH), Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy208, https://doi.org/10.1093/annonc/mdy208

Metastatic Colorectal Cancer
Oral: Final Analysis from the Prospective, Observational CORRELATE Study
In the real-world CORRELATE study, adverse events of regorafenib in patients with metastatic colorectal cancer were generally consistent with the known safety profile. Over 40% of patients received a starting dose of <160 mg/day. Nonetheless, median overall survival and progression-free survival were in the range reported for phase III randomized clinical trials.

Reference: Ducreux et al. O-012: Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice: Final analysis from the prospective, observational CORRELATE study, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.011, https://doi.org/10.1093/annonc/mdy149.011

 

  Metastatic Colorectal Cancer
Oral: Preliminary Results from the Phase IIIb PRECONNECT Study
The phase IIIB PRECONNECT study shows encouraging preliminary safety and efficacy data of trifluridine/tipiracil (FTD/TPI) in patients with pre-treated metastatic colorectal cancer (mCRC). These results are the first data on the widespread clinical use of FTD/TPI outside USA and Japan.

Reference: Falcone et al. O-013: Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer (mCRC): Preliminary results from the phase IIIb, international, open-label, early-access PRECONNECT study, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.012, https://doi.org/10.1093/annonc/mdy149.012

 

  Metastatic Colorectal Cancer
Late-Breaking Abstract: Primary Analysis from the Phase III IMblaze370 Trial
The primary analysis from the phase III IMblaze370 trial did not show statistically significant improvements in overall survival (OS) with atezolizumab monotherapy or with atezolizumab plus cobimetinib versus regorafenib in patients with previously treated, unresectable locally advanced or metastatic colorectal cancer. Median OS: 8.9 months with atezolizumab plus cobimetinib and 8.5 months with regorafenib (HR: 1.00 [95% CI: 0.73–1.38]; p=0.987). 7.1 months with atezolizumab monotherapy (HR vs regorafenib: 1.19 [95% CI: 0.83–1.71]).

Reference: Bendell et al. LBA-004: Efficacy and safety results from IMblaze370, a randomized Phase III study comparing atezolizumab+cobimetinib and atezolizumab monotherapy vs regorafenib in chemotherapy-refractory metastatic colorectal cancer, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy208.003, https://doi.org/10.1093/annonc/mdy208.003

 

  Advanced Gastric or Gastroesophageal Junction Cancer
Late-Breaking Abstract: 
KEYNOTE-061 Phase III Study
In the KEYNOTE-061 phase III study, pembrolizumab did not significantly improve overall survival (OS) in patients with previously treated gastric or gastroesophageal junction cancer (G/GEJ) and PD-L1 combined positive score (CPS) ≥1 when compared with paclitaxel.
Median OS: 9.1 months (95% CI: 6.2–10.7) with pembrolizumab vs 8.3 months (95% CI: 7.6–9.0) with paclitaxel (HR: 0.82 [95% CI: 0.66–1.03]; one-sided p=0.042; p<0.0135 was considered as statistically significant).

Reference: Shitara et al. LBA-005: KEYNOTE-061: Phase 3 study of pembrolizumab vs paclitaxel for previously treated advanced gastric or gastroesophageal junction (G/GEJ) cancer, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy208.004, https://doi.org/10.1093/annonc/mdy208.004

 

  Metastatic Colorectal Cancer
Oral: Safety Lead-In of the BEACON CRC Trial
In the safety lead-in part of the BEACON CRC trial, the triplet regimen encorafenib, binimetinib plus cetuximab was well tolerated in patients with BRAFV600E mutated metastatic colorectal cancer. Observed adverse events were consistent with the known safety profiles of BRAF, MEK and EGFR inhibitors. In addition, this triplet combination showed promising efficacy outcomes in this patient population with progression-free survival that exceeded overall survival seen with standard of care therapy.

Reference: Van Cutsem et al. O-027: BEACON CRC study safety lead-in: Assessment of the BRAF inhibitor encorafenib + MEK inhibitor binimetinib + anti–epidermal growth factor receptor antibody cetuximab for BRAFV600E metastatic colorectal cancer, Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy149.026, https://doi.org/10.1093/annonc/mdy149.026