Melanoma
Opdivo alone has been studied in two main studies in adults with advanced melanoma who have not had surgery. The first study, involving 418 previously untreated patients with advanced melanoma, found that patients treated with Opdivo lived longer than patients given the cancer medicine dacarbazine: 73% of patients treated with Opdivo lived at 12 months in comparison to 42% of patients receiving dacarbazine. In the second study, 405 patients with advanced melanoma whose disease had gotten worse despite previous treatment with a cancer medicine were followed for at least 6 months. About 32% (38 out of 120) of patients treated with Opdivo responded to treatment and experienced a reduction in their tumors, compared with about 11% (5 out of 47) of patients who received a treatment chosen by their doctor (dacarbazine or a combination thereof). carboplatin and paclitaxel).
A third study involving 906 adults with melanoma who had had surgery and were at high risk of the cancer coming back compared Opdivo with ipilimumab. Patients treated with Opdivo lived an average of 31 months before the cancer came back, new melanoma developed or they died, compared with 24 months for patients treated with ipilimumab.
A fourth study in 945 previously untreated adults with advanced melanoma looked at Opdivo in combination with ipilimumab, Opdivo alone or ipilimumab alone. Patients who received Opdivo plus ipilimumab lived for 11.5 months without their disease getting worse, compared with 6.9 months for patients who received Opdivo alone and 2.9 months for patients who received ipilimumab alone. After 2 years with Opdivo and ipilimumab treatment, more patients were alive (64%) than with Opdivo alone (59%) or ipilimumab alone (45%). The study included patients whose cancer cells produced high levels of PD-L1 and patients whose cancer cells produced low levels of PD-L1. Improvements in the time patients lived without their disease getting worse when treated with Opdivo plus ipilimumab compared to Opdivo alone were seen only in patients whose cancer cells produced low levels of PD-L1.
Advanced NSCLC
In non-squamous NSCLC, one main study involved 582 adults whose disease had gotten worse despite previous treatments. The average life expectancy of patients with Opdivo was 12.2 months, compared with 9.4 months with docetaxel (another cancer medicine).
In squamous NSCLC, a study involving 272 adults showed that patients who received Opdivo were alive 9.2 months after starting treatment, compared with 6.0 months for patients who received docetaxel. Supporting information from another study suggested that Opdivo led to a response in patients with squamous NSCLC whose disease had gotten worse despite multiple prior treatments.
In metastatic NSCLC, a study in 719 previously untreated adults showed that patients who received Opdivo in combination with ipilimumab and another cancer medicine lived on average 14 months after starting treatment, compared with 11 months in patients who received other cancer medicines.
Advanced renal cell carcinoma
In one main study, Opdivo was compared with everolimus (another cancer medicine) in 821 patients with advanced renal cell carcinoma whose disease had gotten worse despite previous treatment. Patients given Opdivo lived 25.0 months compared with 19.6 months in patients given everolimus.
Another main study involving 1,096 adults with previously untreated advanced kidney cell carcinoma compared treatment with Opdivo and ipilimumab with treatment with another cancer medicine, sunitinib. At 24 months, 66.5% of patients at intermediate or high risk of their cancer getting worse on the combination were alive, compared with 52.9% in the sunitinib group. In addition, 41.6% of patients (177 out of 423) responded to treatment with the combination, compared with 26.5% (112 out of 416) of patients receiving sunitinib. The time patients lived before their disease got worse was 11.6 months with the combination compared to 8.4 months with sunitinib.
A third main study compared treatment with Opdivo plus cabozantinib with treatment with sunitinib alone in 651 patients with previously untreated advanced renal cell carcinoma or renal cell carcinoma that had spread. In this study, patients treated with Opdivo plus cabozantinib lived on average for about 17 months without their cancer getting worse, while those treated with sunitinib lived for about 8 months without their cancer getting worse.
Classic Hodgkin lymphoma
Opdivo has been studied in one main study and one supportive study involving a total of 95 adults with classical Hodgkin lymphoma whose disease had failed or come back after autologous stem cell transplantation and treatment with the cancer medicine brentuximab vedotin. Opdivo was used on its own and was not compared with other medicines. After treatment, around 66% of the patients (63 out of 95) had their cancer cells partially or completely eliminated.
Advanced SCCHN
Opdivo has been studied in one main study involving 361 adults with SCCHN whose cancer had gotten worse despite previous treatment with medicines containing platinum. Opdivo was used on its own and compared with another cancer medicine (cetuximab, methotrexate or docetaxel) chosen by the treating doctor. Patients given Opdivo lived for an average of 7.5 months, compared with 5.1 months for patients given other treatments.
Urothelkrebs
Opdivo has been studied in one main study involving 270 adults with urothelial cancer whose cancer got worse or came back despite previous treatment with platinum medicines. Opdivo was used on its own and was not compared with other medicines. In the study, 20% of patients (54 out of 270) responded to treatment with a reduction in tumor size.
Another main study involving 709 patients at high risk of their urothelial cancer coming back after having their cancer completely surgically removed showed that Opdivo was effective at preventing the disease from coming back in patients whose cancer produced PD-L1 protein. Patients in this group who received placebo (a dummy treatment) lived an average of 8.4 months before their disease came back; the time period could not be calculated for Opdivo-treated patients because many patients had not had their disease recurrence during a median follow-up of 22 months.
Malignes Pleuramesotheliom
One main study involving 605 patients with malignant pleural mesothelioma that could not be surgically removed looked at how long patients lived when they received Opdivo with ipilimumab or pemetrexed- and platinum-based chemotherapy. In this study, patients who received Opdivo lived for an average of 18 months, while patients who received chemotherapy lived for an average of 14 months.
Advanced colon cancer
A main study involving 119 patients with MSI-H or dMMR colon or rectal cancer looked at the effect of treatment with a combination of Opdivo and ipilimumab. About 65% of patients responded to treatment and had a reduction in tumor size.
Advanced squamous cell carcinoma of the esophagus
One main study involved 419 adults with advanced or metastatic squamous cell carcinoma of the esophagus whose disease had gotten worse or had come back after treatment with fluoropyrimidine and platinum-based chemotherapy, or patients for whom these medicines were unsuitable. In this study, patients treated with Opdivo lived for an average of 11 months, compared with patients treated with docetaxel or paclitaxel who lived for an average of 8 months.
Another main study involved 970 adults with previously untreated esophageal squamous cell carcinoma that could not be surgically removed, had come back or had spread. The study looked at either Opdivo plus ipilimumab or Opdivo plus chemotherapy versus chemotherapy alone.
Patients whose cancer produced PD-L1 protein and treated with Opdivo plus ipilimumab lived for an average of 13.7 months, compared with 9.1 months for patients treated with chemotherapy. There was no difference between the two treatments in the length of time the patients lived without their disease getting worse.
Patients whose cancer produced PD-L1 and who were treated with Opdivo plus chemotherapy lived for an average of 15.4 months compared to 9.1 months for patients treated with chemotherapy alone. In addition, the time patients lived before their disease got worse was 6.9 months with Opdivo plus chemotherapy compared to 4.4 months with chemotherapy alone.
Localized (formerly) esophageal and gastroesophageal junction cancer
A main study involving 794 patients looked at the effect of Opdivo in patients with localized cancer of the esophagus and gastroesophageal junction. All patients still had some cancer cells in their body after chemotherapy, radiotherapy and surgery and were at high risk of the cancer coming back.
In this study, patients who received Opdivo lived for an average of 22 months without their cancer coming back, compared with 11 months for patients who received placebo.
Advanced stomach, gastroesophageal junction, or esophageal adenocarcinoma
In one main study, Opdivo was compared in combination with chemotherapy in 955 adults with previously untreated advanced or metastatic adenocarcinoma of the stomach, gastroesophageal junction or esophagus whose tumors had high levels of PD-L1 (defined as a combined positive score ≥ 5). chemotherapy alone. Patients who received Opdivo and chemotherapy lived an average of 8 months without their disease getting worse and 14 months overall. This compares to 6 months and 11 months for patients who only received chemotherapy.