Apalutamide significantly improves overall survival in patients with non-metastatic castration-resistant prostate cancer
Apalutamide in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22%.
Median overall survival was significantly longer, with 73.9 months for patients receiving treatment with Apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [ hazard ratio, HR=0.78; p=0.0161 ( to reach statistical significance, a p-value of p less than 0.046 needed to be observed ) ].
After the study met its primary endpoint of metastasis-free survival ( MFS ), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to Apalutamide.
The OS results were achieved despite a crossover of 76 randomized placebo patients ( 19% ) to Apalutamide treatment.
After adjusting for the crossover of patients in the placebo arm, the treatment effect of Apalutamide plus ADT exceeded median OS compared to placebo plus ADT with a difference of 21 months between the two arms ( 73.9 months vs 52.8 months, respectively, HR=0.69, p=0.0002 ).
Additionally, treatment with Apalutamide in combination with ADT significantly delayed patients' time to cytotoxic chemotherapy compared to placebo in combination with ADT ( HR=0.63; p=0.0002 ).
Together with data from the primary analysis, the SPARTAN study has met all primary, secondary and exploratory endpoints.
The primary endpoint of the study was MFS; the secondary endpoints were time to metastasis, progression-free survival ( PFS ), time to symptomatic progression, OS and time to initiation of cytotoxic chemotherapy; and the exploratory endpoints were second progression-free survival ( PFS2 ), prostate specific antigen ( PSA ) responses and risk of PSA progression.
Median treatment duration was nearly three times longer for patients treated with Apalutamide plus ADT ( 33 months ) compared with the those treated with placebo plus ADT ( 12 months ).
Grade 3/4 treatment-emergent adverse events of special interest were rash ( 5.2% ), fractures ( 4.9% ), falls ( 2.7% ), ischemic heart disease ( 2.6% ), hypothyroidism ( 0% ) and seizures ( 0% ).
Safety and tolerability of Apalutamide is consistent and as reported previously.
Non-metastatic castration-resistant prostate cancer refers to a disease stage in which the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and/or CT/MRI scan.
Features include: lack of detectable metastatic disease using conventional radiographic imaging and rapidly rising PSA while on ADT with serum testosterone level below 50 ng/dL.
Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.
The relative five-year survival rate for patients diagnosed with a distant-stage prostate cancer is 31%. It is critical to delay the development of metastasis in patients with nmCRPC.
Source: Janssen, 2020
Opdivo in combination with Cabometyx as first-line treatment for patients with advanced renal cell carcinoma, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has approved Opdivo ( Nivolumab ) 240 mg injection for intravenous...
Castration-resistant prostate cancer ( CRPC ) is defined as disease progression during ADT ( androgen deprivation therapy ), with serum...
Opdivo plus Yervoy with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer - Approved in European Union
The European Commission ( EC ) has approved Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles...
Opdivo plus Yervoy for patients with hepatocellular carcinoma previously treated with Sorafenib, FDA approved
Opdivo ( Nivolumab ) 1 mg/kg plus Yervoy ( Ipilimumab ) 3 mg/kg ( injections for intravenous use ) was...
First-line Pembrolizumab monotherapy in advanced non-clear cell renal cell carcinoma: updated follow-up for KEYNOTE-427 cohort B
KEYNOTE-427, a single-arm, open-label, phase 2 study, has shown antitumor activity with first-line Pembrolizumab ( Keytruda ) monotherapy in non-clear...
Apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer: final survival results from SPARTAN, a phase III trial
SPARTAN has evaluated Apalutamide ( Erleada ) versus placebo in patients with nonmetastatic castration-resistant prostate cancer ( nmCRPC ) and...
Atezolizumab + Obinutuzumab + Venetoclax in patients with relapsed or refractory diffuse large B-cell lymphomas: primary analysis of LYSA trial
The treatment of relapsed or refractory diffuse large B-cell lymphoma ( R/R DLBCL ) remains challenging. Atezolizumab ( Tecentriq )...
FDA has approved treatment for patients with endometrial carcinoma: Lenvima in combination with Keytruda
The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center...
Bavencio plus Axitinib combination for first-line treatment of patients with advanced renal cell carcinoma, approved in European Union
The European Commission ( EC ) has approved Bavencio ( Avelumab ) in combination with Axitinib ( Inlyta ) for...