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results
 
 

: IMmotion150

 

Phase 2 Study of Atezolizumab as Monotherapy or in Combination With Bevacizumab Compared to Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (NCT01984242)  
 Sources: 
 Presentation and Review by Dr. Thomas Powles at 2017 Genitourinary Cancers Symposium, February 2017
 Roche Pharma, Switzerland, February 2017  

HOW MANY

people participated in the trial?

A total of 305 patients in 57 cancer centres in various countries worldwide took part in the trial. All patients had previously untreated, locally advanced or metastatic clear cell renal cell carcinoma.

STUDY

DESIGN

What did the study look like?

This phase 2 trial was designed to determine the effectiveness of an immune-oncology treatment (alone and in combination with another therapy) versus the standard first-line therapy for metastatic renal cell carcinoma. This study was designed to be hypothesis-generating, contributing to a phase 3 study now open.

All participating patients were randomly divided into three groups. After this randomisation a total of 305 patients received treatment:

  • 101 patients were treated with atezolizumab plus bevacizumab
  • 101 with sunitinib
  • 103 patients were treated with atezolizumab.
About these medications:
IMmotion150

1) Bevacizumab is given intravenously in combination with a dose of atezolizumab intravenously every 3 weeks

2) Atezolizumab is given intravenously every 3 weeks

3) Sunitinib is taken by mouth once daily for 4 weeks followed by 2 weeks rest.

For further information on the trial, please click here: https://clinicaltrials.gov/ct2/show/study/NCT01984242

RESULTS

of the study

The IMmotion150 trial aimed to answer several questions:

Compared to an existing standard of care TKI (sunitinib) therapy for first-line therapy:

  1. Will the new treatment (atezolizumb alone or in combination with bevacizumab) demonstrate an improvement in the length of time that patients continue to respond to therapy?
  2. Will patients whose tumours express PD-L1 (e.g., are “PD-L1 positive”) have a higher benefit from the new therapies?
  3. What percentage of patients will benefit?
  4. What are the side effects of the therapies and how tolerable are they for patients versus standard treatments?
The following observations could be made from the interim analysis:
  1. Without separating out those patients whose tumours expressed PD-L1, the analysis found no statistically significant difference in progression-free survival (stability) between patients treated with the combination of atezolizumab and bevacizumab and those treated with sunitinib. Atezolizumab alone also did not improve progression-free survival (stability) compared to sunitinib.
  2. However, in the subgroup of patients with PD-L1-positive tumors, the median progression-free survival (stability) period with the combination was 14.7 months versus 7.8 months with sunitinib, and 5.5 months with atezolizumab monotherapy.
    The median duration of response has not yet been reached after 20.7 months of follow-up. More information will be forthcoming so long-term conclusions cannot yet be made.
  3. The percentage of patients who had a measurable response (overall response rate) within all patients was highest with the combination (32%), followed by sunitinib (29%) and atezolizumab alone (25%). In other words, approximately every 3rd patient assigned to the combination therapy had a measurable response.
    However, within the subgroup of PD-L1+ patients, the response rate was 46% with the combination, 28% with atezolizumab alone, and 27% with sunitinib. This means that almost half the pateints with PD-L1+ disease had a measurable response to the combination of atezolizumab and bevacizumab.
  4. Significant side-effects (grade 3 and 4) were seen in 40% of patients treated with the combination of atezolizumab plus bevacizumab, 16% of patients with atezolizumab and and 57% of patients in the sunitinib arm.
    The most common treatment-related side effects occurring in more than 20% of patients receiving atezolizumab plus bevacizumab were:
  • joint pain (arthralgia) (38%),
  • protein in urine (proteinuria) (36%),
  • nosebleed (epistaxis) (28%),
  • itching (pruritus) (22%).
The frequency of severe treatment-related side effects (grade 3 or worse) was similar between patients treated with atezolizumab plus bevacizumab (63%) and sunitinib (69%). One treatment-related death occurred in the atezolizumab plus bevacizumab group. Fifteen of 101 patients (15%) treated with atezolizumab plus bevacizumab discontinued treatment due to side-effects. 61 patients (60%) on the combination arm required a dose modification due to side effects.

CONCLUSION

 

This study is notable because it is the first randomized trial to compare an immune checkpoint inhibitor against a standard treatment of care in patients with previously untreated renal cell carcinoma. However, there were no formal statistical assumptions in the trial, therefore robust statement regarding the results are not possible.

Atezolizumab is an inhibitor of programmed death ligand 1 (PD-L1). Accordingly, the results of the IMmotion 150 trial show that benefit (a higher progression-free survival) with the combination therapy was found only among the subgroup of patients whose tumours expressed PD-L1 and not in the larger group of trial participants.

Results from this phase 2 study strengthen the rationale for the ongoing phase 3 study, IMmotion151, which involves the same three drugs and includes only patients whose tumours have detectable PD-L1 expression.

The Complete Response (CR) rate seen for single agent atezolizumab in this data supports ongoing clinical trials with immune checkpoint inhibitors in the adjuvant setting.

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your experience 

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Disclaimer: This is a patient-friendly summary of the results of this clinical trial which has been medically reviewed, but is provided for informational purposes only.
 
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