Villejuif, may 30, 2017

ASCO 2017

Encouraging results for an immunotherapy in gynaecological cancer    

Nivolumab might be a new effective therapy in patients with failed  treatment of uterine cervical, vaginal and vulval cancers. On 2nd June  Dr Antoine Hollebecque, Head of the Day Hospital Unit in the Drug  Development Department (DITEP) at Gustave Roussy, will present these  results at an oral session at the ASCO Congress.

Nivolumab is an immunotherapeutic agent that has previously been shown  to be effective in various cancers including lung and melanoma. This  clinical study shows its role in gynaecological cancers and offers new hope  for patients in a therapeutic impasse.

The CheckMate 358 clinical trial is a phase 1 / 2 international trial sponsored  by the BMS Company. It is evaluating the efficacy of nivolumab in 5 different  types of cancer, in all of which a viral infection may play a part. Dr Antoine  Hollebecque coordinated the French wing of the study for Gustave Roussy  in a cohort of women with cancers of the uterine cervix, the vagina or vulva,  linked to the human papilloma virus (HPV).

In this cohort, 24 patients received injections of nivolumab at a fixed dose of  240 mg (the standard dose used in other cancers) every two weeks. Nineteen  of them had cervical cancer and 5 had vaginal or vulval cancer. After a  median follow-up period of 31 weeks, the objective response rate (marked  tumour regression) was found in 20.8% of them and the disease control  rate (objective response + stable disease) was 70%. All the responses were  observed among patients with cervical cancer.

Cervical cancer affects about 3,000 women in France each year. Its incidence  is falling as a result of advances in screening by means of smears, but its  mortality remains substantial with some 1,100 deaths per year. More than  90% of cervical cancers are due to HPV infection, usually one dating back  decades to the start of the individual’s sexual activity. Cancers of the vagina  or vulva are rarer but in 40 to 70% of cases these too may result from HPV  infection.

The treatment of these cancers is based on surgery, sometimes combined  with chemotherapy and radiotherapy for advanced forms. When these  treatments fail, if the disease relapses or distant foci (metastases) appear,  there is no useful option to offer these patients.  The anti-PD1 agents, a group to which nivolumab belongs, are one of the  major types of immunotherapy. This anti-cancer mechanism was developed  recently and acts by helping the patient’s own defence mechanisms to fight  the cancer.

PD-1 and PD-L1 are known to be present in gynaecological cancers, which  encouraged the hope that nivolumab might be effective in treating these  tumours. The evidence is now available. The trial also showed that the  drug was well tolerated by patients with its side effects being manageable.  The follow-up period is still too short to draw firm conclusions but overall  survival of these patients also seems to have improved. If these results are  confirmed, nivolumab would become the first immunotherapeutic agent to  be approved for these conditions. 

Oral presentation by Dr Antoine Hollebecque
Session : Gynecologic Cancer
Friday 2nd june, 16h12 (local time)
Place : S406

Title : An Open-Label, Multicohort, Phase 1/2 Study of Nivolumab in Patients With Virus- Associated Tumors (CheckMate 358): Efficacy and Safety in Recurrent or Metastatic (R/M) Cervical, Vaginal, and Vulvar Cancers.
Read abstract N° 5504 on


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