Tough challenges ahead for new gastric-cancer treatments
The treatment of gastric cancer (GC) continues to evolve, with novel innovative modalities poised to disrupt current mainstays such as chemotherapy regimens, Herceptin, Cyramza or Keytruda. Nonetheless, many of the new drug candidates feeding through the R&D pipeline face tough challenges in meeting not only regulatory requirements but oncologist and payer expectations for genuinely improved and differentiated treatment options. How, then, will the GC landscape develop over the next few years? With wide availability of trastuzumab biosimilars can Roche's Herceptin maintain its dominance? What are the consequences for Lilly's Cyramza following disappointing overall-survival data from the RAINFALL study? How have KOLs responded to Keytruda's (Merck & Co.) approval for third-line setting in the US? What stands out for oncologists in a late-stage pipeline encompassing immunotherapies such as nivolumab and avelumab, targeted oral therapies including apatinib and olaparib, and targeted biologics such as claudiximab or andecaliximab? Are these agents sufficiently tailored to patient needs, and distinct from their competitors, to make a real impact on the market? Or do early-stage and next-generation candidates such as margetuximab, epacadostat, AZD6738 or DKN-01 hold out more hope of reshaping treatment strategies?
In this fully updated report, 12 of the world's leading KOLs from the US and Europe offer candid insights on current chemotherapy options, three marketed biologics and 16 experimental drugs in Phase II/III trials for GC.
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- How are KOLs addressing treatment needs in GC? Which chemotherapy regimens and biologics are currently prescribed and in what combinations? What are the options for first-, second and third-line therapy? How do key issues such as biomarker status and tolerability influence treatment choices?
- Is Herceptin's dominant position in the treatment paradigm under threat from biosimilars? Has widespread availability of lower-cost trastuzumab alternatives displaced Herceptin as a first-choice biologic for gastric cancer? Or will new drug combinations in clinical trials expand Herceptin usage and give fresh momentum to Roche's flagship brand?
- Have disappointing results from the Phase III RAINFALL study extinguished Cyramza's hopes of moving into the first line for GC? KOLs analyse the RAINFALL fall-out and the prospects for positioning Cyramza in niche settings such as perioperative therapy or switch maintenance.
- How do KOLs view Keytruda as a new treatment option for GC? Is Merck & Co.'s anti-PD1 coming under pressure from Taiho's Lonsurf in the third-line space? What do the KEYNOTE-61 and KEYNOTE-61 trials bode for extending Keytruda into other treatment settings?
- Are late-stage immunotherapies for GC sufficiently differentiated? A number of immuno-oncology (IO) programmes are advancing through the development pipeline (e.g. nivolumab, avelumab, sintilimab). What are KOLs' expectations for these candidates and how will they stand out in a crowded field?
- What excites KOLs in the mid- and early-stage pipeline for GC? Oncology experts give informed insights into promising developments including oral therapies (e.g, apatinib), targeted biologics (e.g. claudiximab), next-generation immunotherapies (e.g. margetuximab) and targeted oral therapies (e.g. AZD6738).
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"All the efforts to pursue the HER2 pathway inhibition have failed in first, second and third line. The updated results of the ToGA trial have not confirmed the original data showing the three-month gain in survival. So the anti-HER2s are no longer seen as something you cannot do without."
EU Key Opinion Leader
"There are probably slight differences between PD-1 drugs and PD-L1 drugs, certainly in their toxicity profile and mechanism of action. The PD-L1s cause less pneumonitis, which is good. As to their efficacy, it's hard to say."
EU Key Opinion Leader
"For PARP inhibitors, the biomarker question has been worked out, which also opens up an opportunity for being more selective in the trials. Usually for the PARP inhibitors, from sequencing, you could select patients who have problems with DNA-repair pathways, which most probably account for around 30 percent of gastric cancer, if not more."
US Key Opinion Leader
Sample of therapies covered
- Cyramza (ramucirumab; Lilly)
- Herceptin (trastuzumab; Roche/Genentech)
- Keytruda (pembrolizumab; Merck & Co.)
Late Stage Pipeline Programmes
- Apatinib (LSK Biopharma)
- Avelumab (Bavencio; Merck Group/Pfizer)
- Nivolumab (Opdivo; BMS/Ono)
- Olaparib (Lymparza; AstraZeneca)
- Pamiparib (BeiGene)
Early Stage Pipeline Programmes
- AZD6738 (AstraZeneca)
- Bemarituzumab (Five Prime Therapeutics)
- DKN 01 (Leap/Merck & Co.)
- Durvalumab (Imfinzi; AstraZeneca)
- Margetuximab (MacroGenics)
KOLs from North America
- Andrew Ko. Professor, Department of Medicine (Hematology/Oncology), UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.
- Bassel El-Reyes. Professor and Vice Chair for Clinical Research, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.
- Benjamin Musher. Associate Professor, Medicine-Hematology and Oncology, Baylor College of Medicine, Houston, TX.
- Daniel Catenacci. Assistant Professor of Medicine, University of Chicago Medical Center, Chicago, IL.
- Jaffer Ajani. Professor, Tenure Track, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX.
- Michael A. Morse. Professor of Medicine, Professor in the Department of Surgery, Member of the Duke Cancer Institute, Department of Medicine, Duke University School of Medicine, Durham, NC.
KOLs from Europe
- Alberto Sobrero. Medical Oncology Unit, Ospedale San Martino, Genova, Italy
- Elisabeth Smyth. Clinical Research Fellow, GI & Lymphoma Department, The Royal Marsden NHS Foundation Trust, Sutton, UK, and Lead Author on ESMO Gastric Cancer Treatment Guidelines.
- Eric Van Cutsem. Professor of Internal Medicine at the University of Leuven, Head of the Digestive Oncology Unit at the University Hospital Gasthuisberg in Leuven, Belgium.
- John Bridgewater. Consultant Medical Oncologist, University College London Hospitals, UK
- Maria Alsina. Department of Medicine, Autonomous University of Barcelona, Spain
- Michael Davidson. Research Fellow, The Royal Marsden NHS Foundation Trust, Sutton, UK.
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