New Phase III data show Novartis tislelizumab significantly extended median overall survival by more than 6 months in first-line advanced esophageal cancer in combination with chemotherapy
- First-line tislelizumab plus chemotherapy showed median overall survival of 17.2 months versus 10.6 months for chemotherapy and reduced risk of death by 34% in patients with advanced esophageal squamous cell carcinoma1
- Statistically significant survival benefit with tislelizumab plus chemotherapy was observed regardless of PD-L1 status and consistent across all patient subgroups1
- Novartis to discuss results of multi-regional RATIONALE 306 study, the seventh positive Phase III trial readout for tislelizumab, with regulatory health authorities
Basel, June 30, 2022 — Today Novartis announced results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status. Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34% (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001).1 In collaboration with BeiGene, these data were presented today during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer (Abstract #LBA-1).
“These data, which show tislelizumab plus chemotherapy extended patients’ lives by a median of more than six months, are a promising outcome in the treatment of this aggressive cancer,” said Dr. Ken Kato, Chief of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. “Importantly, the significant overall survival benefit was observed across all patient subgroups in the trial, indicating that tislelizumab plus chemotherapy may be a viable treatment option for patients regardless of their PD-L1 score.”
In patients with PD-L1 score ≥10% (secondary endpoint), tislelizumab plus chemotherapy showed a median OS of 16.6 months (CI, 15.3-24.4 months) versus 10.0 months (CI, 8.6-13.0 months) in patients receiving chemotherapy plus placebo and reduced risk of death by 38% (HR=0.62; CI, 0.44-0.86, p=0.0020). In those with PD-L1 score <10% (exploratory analysis), median OS with tislelizumab plus chemotherapy was 16.7 months (CI, 13.0-20.1 months) versus 10.4 months (CI, 9.1-13.0 months; HR=0.72; CI, 0.55-0.94). Survival benefit was consistent across all other subgroups, including race, geographical region and investigator choice of chemotherapy. Tislelizumab plus chemotherapy also significantly improved progression-free survival (7.3 months vs 5.6 months; HR=0.62; CI, 0.52-0.75, p<0.0001) and objective response rate (63.5% vs 42.4%; odds ratio=2.38, p<0.0001).1
“The prognosis for ESCC remains poor, with a five-year survival rate of just five percent, and patients are in need of more treatment options, especially in earlier lines of therapy,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. “These results add to the growing body of evidence demonstrating the potential for tislelizumab to help patients with esophageal cancer, and reinforce our commitment to studying tislelizumab alone and in synergistic combinations across additional tumor types that may benefit from an immunotherapy.”
The incidence of treatment-related adverse events (TRAEs) was similar in both arms. Most common TRAEs for tislelizumab plus chemotherapy versus chemotherapy were anemia (68% vs 61%), decreased neutrophils (78% vs 80%), decreased white blood cell count (55% vs 65%), decreased appetite (39% vs 38%), nausea (37% vs 42%) and peripheral sensory neuropathy (26% vs 21%).1
ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.2 In the United States, it is estimated there will be more than 20,000 new diagnoses and more than 16,000 deaths from esophageal cancers.3
RATIONALE 306 (NCT03783442) is a multi-regional Phase III, randomized, placebo-controlled, double-blind study of tislelizumab in combination with chemotherapy versus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic ESCC. Approximately 649 study participants were randomized 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy plus placebo. The primary endpoint is OS in the all-comer intent-to-treat population. Secondary endpoints include OS in patients with PD-L1 score ≥10%, progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety.
Tislelizumab is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.
Tislelizumab is a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 17 pivotal clinical trials across a broad array of solid tumors, with more than 9,000 patients enrolled to date in 35 countries and regions. Novartis broad portfolio of advanced therapeutic approaches offer a unique opportunity to study tislelizumab in differentiated, potentially synergistic combinations.
Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact firstname.lastname@example.org
- Yoon H, Kato K, Raymond E et al. RATIONALE-306: Randomized, global, placebo-controlled, double-blind Phase 3 study of tislelizumab plus chemotherapy versus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma. Presented at ESMO-GI on 30 June 2022 (#LBA1).
- Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians. 2021;71(3):209-249.
- American Cancer Society. Key statistics for esophageal cancer. Accessed March 1, 2022. https://www.cancer.org/cancer/esophagus-cancer/about/key-statistics.html
# # #
Novartis Media Relations
| Anja von Treskow|
Novartis External Communications
+41 79 392 8697 (mobile)
Novartis US External Communications
+1 862 579 8456
| Michael Billings|
+1 201 400 1854 (mobile)
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 345 4440|
|Nicole Zinsli-Somm||+41 61 324 3809||Alina Levchuk||+1 862 778 3372|
|Isabella Zinck||+41 61 324 7188||Parag Mahanti||+1 973 876 4912|
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Mandatory Notification of Trade15.8.2022 15:47:26 CEST | Press release
Please refer to the attached form of notification of transaction by primary insider under the DNO ASA Employee Synthetic Share Program. This notification has been submitted pursuant to the Securities Trading Act § 5-12 and MAR Article 19 no. 3. Attachment Form of Notification Settlement of Synthetic Shares Tom Allan
Stevie® Awards Announce Winners in 19th Annual International Business Awards® from Across the Globe15.8.2022 13:00:00 CEST | Press release
3,700 Nominations Were Submitted from Organizations in 67 Nations FAIRFAX, Va., Aug. 15, 2022 (GLOBE NEWSWIRE) -- High-achieving organizations and executives around the world have been recognized as Gold, Silver, and Bronze Stevie® Award winners in The 19th Annual International Business Awards®, the world's only international, all-encompassing business awards program. Winners were selected from more than 3,700 nominations submitted by organizations in 67 nations. A complete list of all 2022 Gold, Silver and Bronze Stevie Award winners by category is available at www.StevieAwards.com/IBA. More than 300 executives worldwide participated on 11 juries to determine the Stevie winners. The top winner of Gold, Silver, and Bronze Stevie Awards is HALKBANK of Istanbul, Turkey with 32. Other winners of multiple Stevie Awards include IBM Corporation (21), LLYC (20), Deutsche Post DHL (19), Abu Dhabi Ports Group (17), Viettel Group (17), OPET (15), Telkom Indonesia (13), ZER (13), Ayala Land Inc.
Bergman & Beving acquires Polartherm15.8.2022 13:00:00 CEST | Press release
Press release Bergman & Beving acquires Polartherm Bergman & Beving has today acquired 80 per cent of the shares in Polartherm Group. Polartherm is a leading player within powerful, mobile heaters for certain niches within industry, construction and aviation. Polartherm has an annual revenue of approximately MEUR 12 with good profitability. The business is based in Luvia and Kokemäki in Finland and has 57 employees. ”Polartherm has a market leading position within mobile heaters with impressive customer base within inter alia the aviation and defence sectors around the world. Our ambition with the company is now to further enhance the growth journey which the company’s management has already initiated”, says Oscar Fredell, Head of Division Tools & Consumables. “We are looking forward to joining Bergman&BevingGroup. Due to its long-term and stable position we consider it a suitable majority owner for Polartherm going forward”, says the managing director and part-owner Pasi Anttila who w
Bergman & Beving förvärvar Polartherm15.8.2022 13:00:00 CEST | Pressemelding
Pressmeddelande Bergman & Beving förvärvar Polartherm Bergman & Beving har idag förvärvat 80 procent av aktierna i Polartherm Group. Polartherm är en ledande aktör inom kraftfulla, mobila värmeaggregat för nischområden inom industri-, bygg- och flygbranscherna. Polartherm omsätter cirka 12 MEUR per år med god lönsamhet. Verksamheten är baserad i Luvia och Kokemäki i Finland och har 57 anställda. ”Polartherm har en marknadsledande position inom mobila värmeaggregat med en imponerande kundbas inom bl.a. flyg- och försvarssektorerna runtom i världen. Vårt mål med bolaget blir nu att förstärka den tillväxtresa som bolagets ledning redan påbörjat”, säger Oscar Fredell, divisionschef Tools & Consumables. ”Vi ser fram emot att bli en del av Bergman&Bevingkoncernen. Med sin långsiktiga och stabila position ser vi dem som en lämplig huvudägare för Polartherm framåt”, säger VD:n och delägaren Pasi Anttila, som fortsätter som VD och minoritetsägare i bolaget. Polartherm kommer att ingå i division
Nordic American Tankers Ltd (NYSE: NAT) – Update on contracts15.8.2022 12:36:19 CEST | Press release
Monday, August 15, 2022 Dear Shareholders and Investors, Below are the latest contracts for our suezmax ships, showing the level of the market. The rates we experience now are far above recent quarters. 12th Aug.: Vessel fixed on subjects to US Oil Major for voyage from Mediterranean to Asia. Time Charter Equivalent (TCE) about USD 60,000 over 35 days 12th Aug.: Vessel fixed on subjects to Asian interests for voyage from AG to Singapore. Time Charter Equivalent (TCE) about USD 19,000 over 36 days 4th Aug.: Vessel fixed to Asian interests for voyage cross Mediterranean. Time Charter Equivalent (TCE) about USD 40,000 over 15 days 3rd Aug.: Vessel fixed to Asian interests for voyage from Red Sea to Asia. Time Charter Equivalent (TCE) about USD 21,500 over 45 days 28th July: Vessel fixed to Asian interests for voyage from AG to Singapore. Time Charter Equivalent (TCE) about USD 46,500 over 26 days 25th July: Vessel fixed to American interests for voyage (positioning voyage) from AG to US G