Colorectal Cancer: Latest Developments

Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in colorectal cancer. For general information about the disease, see the Colorectal Cancer page.

• • Promising Studies
  • Congress · ESMO 2026
  • Colorectal Cancer
  • 25 October 2026

  Dostarlimab alone led to a clinical complete response in a substantial proportion of patients with dMMR/MSI-H locally advanced rectal cancer (AZUR-1, phase 2)

  In a small proportion of rectal cancers, a defect in the DNA repair system (dMMR/MSI-H) makes the tumour highly sensitive to immunotherapy. In locally advanced disease the standard approach combines chemotherapy, radiotherapy and surgery, which can cause lasting problems with bowel, urinary and sexual function. In the international phase 2 AZUR-1 trial, 154 previously untreated patients received the immunotherapy drug dostarlimab alone for about 6 months. By investigator assessment, the tumour disappeared on examination and imaging in 68% of patients followed for at least 12 months, and this lasted at least 12 months; including complete responses in patients who had surgery, the rate was 76%. By independent central review the rate is currently 47% (the 12-month assessment is not yet complete for some patients). At about 26 months of follow-up, no recurrences were reported among patients with a complete response. Severe immune-related side effects occurred in a small number of patients. This is an interim analysis without a comparison group; long-term recurrence risk and quality-of-life data are not yet known. In the USA (FDA) this use has received accelerated approval; its licensing and reimbursement status in Europe and Turkey has not been verified. The tumour must first be shown to be dMMR/MSI-H with reliable tests. A decision to monitor without surgery requires joint assessment by medical oncology, general surgery, radiation oncology, gastroenterology (endoscopy), radiology and pathology, and regular close follow-up.

  These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

  Status in Turkey: Dostarlimab is licensed in Turkey (TİTCK licence date 19.01.2026); it is not on the SGK EK-4/A list dated 23.10.2026. The indication and reimbursement status for this rectal cancer use could not be verified.

  • Source:
  • ESMO news (27 October 2026)
  • ESMO Congress 2026, LBA87 abstract
  • FDA announcement (19 October 2026)
• • Promising Studies
  • Congress · ESMO 2026
  • Colorectal Cancer
  • 24 October 2026

  Nivolumab plus ipilimumab in MSI-H/dMMR metastatic colorectal cancer: final survival results after more than 5 years of follow-up (CheckMate 8HW)

  A small proportion of colorectal cancers (MSI-H/dMMR) are particularly sensitive to immunotherapy. The phase 3 CheckMate 8HW trial compared the combination of two immunotherapy drugs (nivolumab + ipilimumab) with nivolumab alone and with chemotherapy in this type of colorectal cancer that has spread (metastatic). In the final analysis, with median follow-up of more than 5.5 years, the combination reduced the risk of death by about 39% compared with nivolumab alone across all lines of treatment, and by about 63% compared with chemotherapy in the first line. In the first line, the survival difference between the combination and nivolumab alone favoured the combination but was not statistically significant. No new safety concerns were reported with long follow-up; the known side effects of immunotherapy require close monitoring. This treatment is approved in the USA (FDA) for this use; licensing and SGK reimbursement conditions in Turkey must be assessed separately. The tumour must first be shown to be MSI-H/dMMR with reliable tests. Treatment is chosen through joint assessment by medical oncology, surgery, radiology and pathology.

  These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

  Status in Turkey: Nivolumab (TİTCK licence date 19.04.2017) and ipilimumab (05.06.2014) are licensed in Turkey and are on the SGK EK-4/A list dated 23.10.2026; reimbursement is limited to the conditions in the SUT. The indication and reimbursement scope of the combination in MSI-H/dMMR metastatic colorectal cancer could not be verified.

  • Source:
  • ESMO Congress 2026, LBA32 abstract
  • FDA announcement (8 April 2025)
• • FDA Approval
  • Colorectal Cancer
  • 19 October 2026

  Dostarlimab received FDA accelerated approval for stage II–III MSI-H/dMMR locally advanced rectal cancer

  The FDA granted accelerated approval to dostarlimab alone for previously untreated stage II–III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR). The decision is based on the AZUR-1 trial: 154 patients received dostarlimab every three weeks for nine cycles; patients with a clinical complete response were followed without surgery, with close endoscopy and MRI monitoring. By independent central review, 47% had a complete response lasting at least 12 months and the objective response rate was 79%; 38 more patients were in complete response but had not yet reached 12 months of follow-up. 71% of patients were being followed without surgery, radiation or additional drug treatment and without disease progression. The FDA also reviewed a second, 50-patient trial in which the 12-month complete response rate was 93%. Accelerated approval depends on confirmation with longer follow-up that the results are sustained. Warnings include immune-mediated adverse reactions and infusion-related reactions. Eligibility is determined by MSI/MMR testing of tumour tissue; the decision should be made jointly by the surgeon, radiation oncologist and medical oncologist.

  Status in Turkey: Dostarlimab is licensed in Turkey (TİTCK licence date 19.01.2026); it is not on the SGK EK-4/A list dated 02.10.2026. The indication and reimbursement status of this rectal cancer use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (19 October 2026)
• • FDA Approval
  • Colorectal Cancer
  • 8 October 2026

  Atezolizumab, together with adjuvant chemotherapy, received FDA approval for stage III dMMR colon cancer

  The FDA approved atezolizumab for use with a fluoropyrimidine and oxaliplatin in the postoperative (adjuvant) treatment of stage III colon cancer with mismatch repair deficiency (dMMR) whose tumour has been completely removed surgically. The decision is based on the ATOMIC trial: 712 patients were randomised to receive 12 cycles of mFOLFOX6 plus atezolizumab (followed by 6 months of atezolizumab alone) or mFOLFOX6 alone. The hazard ratio for disease-free survival was 0.50, which corresponds to roughly a halving of the risk of recurrence or death. Median values were not reached in either arm. dMMR status is determined by testing tumour tissue and is seen in a subgroup of stage III colon cancers. Warnings include immune-mediated adverse reactions.

  Status in Turkey: Atezolizumab is licensed in Turkey for other indications; the licence and reimbursement status of this adjuvant colon cancer use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (8 October 2026)
• • FDA Approval
  • Colorectal Cancer
  • 24 February 2026

  Encorafenib combination converted to full approval in BRAF V600E-mutant metastatic colorectal cancer

  The FDA granted full (traditional) approval to encorafenib, together with cetuximab and fluorouracil-based chemotherapy, for use in BRAF V600E-mutant metastatic colorectal cancer. The combination had received accelerated approval with mFOLFOX6 in 2024. The decision is based on the BREAKWATER trial, which enrolled previously untreated patients. Median progression-free survival was 12.8 months in the encorafenib, cetuximab and mFOLFOX6 arm and 7.1 months in the standard chemotherapy arm (hazard ratio 0.53). Median overall survival was 30.3 and 15.1 months, respectively (hazard ratio 0.49). In the first 110 patients randomised in each arm, the objective response rate was 61% versus 40%. The BRAF V600E mutation occurs in a subgroup of metastatic colorectal cancers and is tested for by molecular testing at diagnosis.

  Status in Turkey: Encorafenib is licensed in Turkey (TİTCK, 2023) but is not on the SGK EK-4/A list; the reimbursement status of this use has not yet been clarified.

  • Source:
  • FDA announcement (24 February 2026)
• • Promising Studies
  • Colorectal Cancer
  • 18 September 2025

  Low-dose aspirin reduced recurrence in colorectal cancer with PI3K pathway alterations

  The ALASCCA trial, published in the New England Journal of Medicine, compared 160 mg of aspirin daily for three years with placebo in patients with operated stage I–III rectal or stage II–III colon cancer whose tumour had an alteration in PI3K signalling pathway genes. The three-year recurrence rate was 7.7% with aspirin and 14.1% with placebo in the group with a PIK3CA hotspot mutation (hazard ratio 0.49). In the group with other PI3K alterations, the rates were 7.7% and 16.8% (hazard ratio 0.42). Serious adverse events occurred in 16.8% of the aspirin arm and 11.6% of the placebo arm. Although the results are promising, aspirin should not be started before it is reflected in guidelines and the individual bleeding risk has been assessed; this decision must always be made together with a physician.

  Status in Turkey: Aspirin is a licensed medicine in Turkey; however, its use to prevent recurrence in colorectal cancer is not an approved indication.

  • Source:
  • Martling A et al. N Engl J Med 2025;393:1051-1064
  • PubMed 40961426
• • Promising Studies
  • Colorectal Cancer
  • 1 June 2025

  A structured exercise programme after chemotherapy prolonged disease-free survival in colon cancer

  In the phase 3 CHALLENGE trial published in the New England Journal of Medicine, 889 patients with colon cancer who had completed surgery and adjuvant chemotherapy were randomised to a three-year structured exercise programme or to a group receiving only health education material. At a median follow-up of 7.9 years, disease-free survival was longer in the exercise group (hazard ratio 0.72); five-year disease-free survival was 80.3% versus 73.9%. Overall survival findings also favoured the exercise group (hazard ratio 0.63; eight-year survival 90.3% versus 83.2%). Musculoskeletal adverse events were more common in the exercise group (18.5% versus 11.5%). This is not a drug approval; the study provides strong data that exercise can be a planned part of post-treatment care.

  Status in Turkey: This is not a matter of licensing or reimbursement; the appropriate level of exercise should be planned together with a physician and a physiotherapist.

  • Source:
  • Courneya KS et al. N Engl J Med 2025;393:13-25
  • PubMed 40450658

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The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.