Pressemelding -
ASCO 2018: Kombinasjonsbehandling i førstelinje med Roches immunterapi Tecentriq®▼ gir 4,5 måneder overlevelsesgevinst innen lungekreft
- Fase III-studien IMpower150 viser at behandling med immunterapien Tecentriq (atezolizumab) og Avastin (bevacizumab), i kombinasjon med kjemoterapi , gir en statistisk signifikant forlengelse av median overlevelse med 4,5 måneder sammenlignet med Avastin og kjemoterapi (median overlevelse: 19,2 måneder versus 14,7 måneder). Studien ble gjennomført hos pasienter med ikke-småcellet lungekreft (NSCLC) med ikke-plateepitel histologi.
- En forlenget median overlevelse i favør av Tecentriq + Avastin og kjemoterapi ble sett i alle subgrupper av pasienter, inkludert de med ALK/EGFR-mutasjoner og levermetastaser, uansett PD-L1-uttrykk.
- Sikkerhetsprofilen av behandling med Tecentriq + Avastin og kjemoterapi var som forventet og ingen nye, ukjente bivirkninger ble sett i studien.
- IMpower150 er den første studien med Tecentriq i kombinasjon med Avastin og kjemoterapi som førstelinjebehandling av ikke-småcellet lungekreft som viser en klinisk relevant effekt,særlig hos pasienter med EGFR- og ALK-mutasjoner, og pasienter med levermetastaser.
Les Roches internasjonale pressemelding for nærmere informasjon:
Basel, 17th May 2018
Phase III IMpower150 study showed Roche’s TECENTRIQ® and Avastin® plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel
- A survival advantage for the TECENTRIQ and Avastin combination regimen was observed in all pre-specified exploratory patient subgroups analysed, including people with EGFR and ALK mutations, liver metastases and those with varying levels of PD-L1 expression
- Data will be presented at American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2018
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III IMpower150 study of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) for the initial (first-line) treatment of chemotherapy-naïve people with metastatic non-squamous non-small cell lung cancer (NSCLC). This interim analysis showed that TECENTRIQ and Avastin plus carboplatin and paclitaxel helped people live significantly longer compared with Avastin plus carboplatin and paclitaxel (median overall survival [OS] = 19.2 versus 14.7 months; hazard ratio [HR] = 0.78, 95% CI: 0.64-0.96; p=0.016) in the intention-to-treat wild-type (ITT-WT) population, a co-primary endpoint of the study.1 An OS advantage was observed in all pre-specified exploratory biomarker-selected subgroups analysed, which included people with EGFR- and ALK-positive mutations who had received an appropriate targeted therapy, and those with varying levels of PD-L1 expression or with negative PD-L1 expression. People with liver metastases treated with the TECENTRIQ combination also had a survival advantage. The safety profile of the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.
“The IMpower150 study results showed a significant survival benefit, adding to the clinical evidence supporting the combination of TECENTRIQ and Avastin as an initial treatment for metastatic non-squamous non-small cell lung cancer. An overall survival benefit was also observed in key populations such as people with EGFR- and ALK-positive mutations and those with liver metastases,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are working with health authorities around the world to bring this potential TECENTRIQ combination regimen to people living with this disease.”
At this interim analysis, the combination of TECENTRIQ plus carboplatin and paclitaxel (Arm A) did not show a statistically significant OS benefit when compared to the combination of Avastin plus carboplatin and paclitaxel (Arm C). Arm A will continue as planned to the final analysis. Safety in the TECENTRIQ plus carboplatin and paclitaxel arm appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
The official data presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting will be on Monday, June 4, 2018, at 15:45 – 15:57 p.m. CDT (Abstract #9002).
The combination of TECENTRIQ and Avastin plus carboplatin and paclitaxel was recently granted Priority Review from the U.S. Food and Drug Administration (FDA) for the initial (first-line) treatment of chemotherapy-naïve people with metastatic non-squamous NSCLC. The FDA is expected to make a decision on approval by September 5th, 2018.
IMpower150 is one of eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines. Following the IMpower150 and IMpower131 studies, three more Phase III lung cancer studies are expected to report this year.
About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people of which those with ALK and EGFR mutations were excluded from the primary ITT analysis. People were randomised (1:1:1) to receive:
- TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
- TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
- Avastin plus carboplatin and paclitaxel (Arm C, control arm).
During the treatment-induction phase, people in Arm A received TECENTRIQ administered intravenously at 1200 mg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. Following the induction phase, people received maintenance treatment with TECENTRIQ (1200 mg every 3 weeks) until loss of clinical benefit or disease progression. IMpower150 was designed to formally compare TECENTRIQ plus chemotherapy (Arm A) versus Avastin plus chemotherapy (Arm C), only if TECENTRIQ and Avastin plus chemotherapy (Arm B) is shown to improve OS in the ITT-WT population compared to Avastin plus chemotherapy (Arm C).
People in Arm B received induction treatment with TECENTRIQ (1200 mg) and Avastin administered intravenously at 15 mg/kg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. People then received maintenance treatment with the TECENTRIQ Avastin regimen until disease progression (Avastin) or loss of clinical benefit/disease progression (TECENTRIQ).
People in Arm C received induction treatment with Avastin administered intravenously at 15 mg/kg plus intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. This was followed by maintenance treatment with Avastin alone until disease progression.
The co-primary endpoints were PFS and OS, as determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). The co-primary OS endpoint in IMpower150 was assessed in all randomised people without an EGFR or ALK genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population and in EGFR and ALK mutation subgroups. The study met its co-primary endpoints of OS and PFS per study protocol.
A summary of OS results are included below.
| Table. Arm B (TECENTRIQ and Avastin plus chemotherapy) vs Arm C (Avastin plus chemotherapy) OS in Populations of Interest | ||||
| Population | No. of Pts | HR (95% CI) | mOS, mo | |
| Arm B | Arm C | |||
| ITT-WTa | 696 | 0.78 (0.64, 0.96) | 19.2 | 14.7 |
| ITT | 800 | 0.76 (0.63, 0.93) | 19.8 | 14.9 |
| EGFR/ALK+ | 104 | 0.54 (0.29, 1.03) | NR | 17.5 |
| Liver metastasesb | 94 | 0.54 (0.33, 0.88) | 13.2 | 9.1 |
| Subgroups in ITT-WT | ||||
| TC1/2/3 or ICI1/2/3 | 357 | 0.77 (0.58, 1.04) | 22.5 | 16.4 |
| TC0 and IC0 | 339 | 0.82 (0.62, 1.08) | 17.1 | 14.1 |
| Teff-high | 285 | 0.83 (0.59, 1.17) | 25.0 | 16.7 |
| Teff-low | 377 | 0.78 (0.60, 1.02) | 17.6 | 14.3 |
| IC, tumour-infiltrating immune cells; NE, not estimable; TC, tumour cells. a WT excludes patients with EGFR or ALK genomic alterations. b Present at baseline . TC1/2/3 or ICI1/2/3 = PD-L1+ ≥ 1% of TC or IC; TC0 and IC0 = PD-L1+ < 1% of TC and IC. |
The safety profile of the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination. Serious adverse events (Grade 3-4) related to treatment were observed in 57% of people who received TECENTRIQ and Avastin plus carboplatin and paclitaxel compared to 49% of those who received Avastin plus carboplatin and paclitaxel.
About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.3 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.4
About TECENTRIQ® (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T-cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.
About Avastin® (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour's ability to grow and spread in the body (metastasise).
About the TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) combination
There is a strong scientific rationale to support the use of TECENTRIQ plus Avastin in combination. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
*EGFR: Epidermal Growth Factor Receptor
†ALK: Anaplastic Lymphoma Kinase
References
1.Socinski M et al. Overall Survival (OS) analysis of IMpower150, a randomized Ph 3 study of atezolizumab (atezo) + chemotherapy (chemo) ± bevacizumab (bev) vs chemo + bev in 1L non squamous (NSQ) NSCLC. To be presented at: ASCO Annual Meeting; 2018 Jun 1-5; Chicago, IL, USA. Abstract #9002
2.Ferlay J et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide. IARC CancerBase No. 11 [Internet]. Lyon France: International Agency for Research on Cancer; 2013. Available from:http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed October 2017.
3.Barzi A, Pennell NA. Targeting angiogenesis in non-small cell lung cancer: agents in practice and clinical development. European J Clin Med Oncol 2010; 2(1):31–42.
4.American Cancer Society; last accessed February 2018: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html
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