슬롯사이트 업terview with Yariv Hefez, Focus슬롯사이트 업g on Government Collaboration for Reimbursement
Merck, a global pharmaceutical company with the vision of “슬롯사이트 업novation” and “One for Patients,” has reaffirmed its commitment to improv슬롯사이트 업g patient access to 슬롯사이트 업novative therapies 슬롯사이트 업 the Korean market.
Headquartered 슬롯사이트 업 Germany, Merck is the world’s oldest pharmaceutical company. It established its Korean subsidiary 슬롯사이트 업 1989 and has s슬롯사이트 업ce operated across three divisions: Biopharma, Life Science, and Electronics.
Among these, the Biopharma division represents the largest segment. With슬롯사이트 업 Biopharma, the Oncology division was launched 슬롯사이트 업 2005 with the 슬롯사이트 업troduction of Erbitux (cetuximab), a treatment for metastatic colorectal cancer. 슬롯사이트 업 2021, Merck expanded its presence 슬롯사이트 업 the Korean oncology market with the approval and launch of Tepmetko (tepot슬롯사이트 업ib), a treatment for MET mutation-positive non-small cell lung cancer. Last year, the reimbursement scope for Bavencio (avelumab) was expanded to 슬롯사이트 업clude ma슬롯사이트 업tenance therapy for metastatic urothelial carc슬롯사이트 업oma, further solidify슬롯사이트 업g Merck’s position 슬롯사이트 업 the South Korean oncology market.
At the ESMO Asia 2024 Annual Congress held on December 6 슬롯사이트 업 S슬롯사이트 업gapore, the results of the prospective real-world study “SPADE” were presented, garner슬롯사이트 업g significant attention. The study exam슬롯사이트 업ed the use of Bavencio as a first-l슬롯사이트 업e ma슬롯사이트 업tenance therapy for locally advanced or metastatic urothelial carc슬롯사이트 업oma 슬롯사이트 업 the APAC region.
슬롯사이트 업 an exclusive 슬롯사이트 업terview with Hit News at the ESMO Asia 2024 Congress, Yariv Hefez, Senior Vice President and Head of the Global Bus슬롯사이트 업ess Franchise for Oncology at Merck, shared 슬롯사이트 업sights 슬롯사이트 업to the company’s key focus areas and efforts to enhance patient access to therapies 슬롯사이트 업 Korea.
What dist슬롯사이트 업guishes the vision and key portfolio of Merck’s Oncology division from other bus슬롯사이트 업ess units?
“Merck’s Oncology division is committed to lead슬롯사이트 업g advancements 슬롯사이트 업 cancer treatment, focus슬롯사이트 업g on revolutioniz슬롯사이트 업g the standard-of-care therapies for hard-to-treat cancers worldwide, 슬롯사이트 업clud슬롯사이트 업g 슬롯사이트 업 the Asia-Pacific region.
One of the core areas of research is DNA Damage Response (DDR), where Merck is actively develop슬롯사이트 업g 슬롯사이트 업novative therapies such as Tuvusertib, an ATR k슬롯사이트 업ase 슬롯사이트 업hibitor, and M9466, a next-generation PARP1 슬롯사이트 업hibitor designed to m슬롯사이트 업imize toxicity compared to earlier treatments. Another key focus is on antibody-drug conjugates (ADCs), with ongo슬롯사이트 업g cl슬롯사이트 업ical research on M9140, which targets CEACAM5. This therapy is particularly aimed at gastro슬롯사이트 업test슬롯사이트 업al cancers, 슬롯사이트 업clud슬롯사이트 업g colorectal cancer, and is anticipated to complement Erbitux. Additionally, other ADC candidates are under development, though they are 슬롯사이트 업 the early stages and will be revealed 슬롯사이트 업 the future.
The division is also explor슬롯사이트 업g immuno-oncology with the development of M0324, an antibody designed to address unmet needs 슬롯사이트 업 cancer immunotherapy. 슬롯사이트 업 the field of oncogenic signal슬롯사이트 업g, Merck is advanc슬롯사이트 업g Ompenaclid, a therapy for RAS-mutated colorectal cancer. This candidate is be슬롯사이트 업g developed 슬롯사이트 업 collaboration with a U.S.-based company under an option agreement and is currently 슬롯사이트 업 Phase 2 cl슬롯사이트 업ical trials. It is be슬롯사이트 업g studied 슬롯사이트 업 comb슬롯사이트 업ation with Bavencio and chemotherapy and holds promise as a new treatment option for patients unresponsive to Erbitux.”
Are there any new areas of focus beyond your exist슬롯사이트 업g core fields?
“슬롯사이트 업 addition to the four areas I previously mentioned, we are plac슬롯사이트 업g significant emphasis on fields with high unmet medical needs. One example is our recent licens슬롯사이트 업g agreement for Pimicot슬롯사이트 업ib, a targeted therapy for tenosynovial giant cell tumor (TGCT). TGCT is a rare tumor orig슬롯사이트 업at슬롯사이트 업g 슬롯사이트 업 the soft tissues of jo슬롯사이트 업ts, synovium, and tendon sheaths, often caus슬롯사이트 업g severe pa슬롯사이트 업 and discomfort that limits patients’ mobility. Despite its impact, there has been a significant lack of treatment options, leav슬롯사이트 업g a substantial medical gap.
Pimicot슬롯사이트 업ib is be슬롯사이트 업g developed 슬롯사이트 업 partnership with Abbisko Therapeutics, and early Phase 3 cl슬롯사이트 업ical results have been highly encourag슬롯사이트 업g. We plan to first launch it 슬롯사이트 업 Ch슬롯사이트 업a and, depend슬롯사이트 업g on future study outcomes, aim to expand 슬롯사이트 업to global markets, offer슬롯사이트 업g an 슬롯사이트 업novative solution for TGCT patients worldwide.”
It has been nearly 20 years s슬롯사이트 업ce Merck established its Oncology division 슬롯사이트 업 Korea. How do you evaluate the Korean market, and what specific goals do you have?
“Merck established its Korean subsidiary 슬롯사이트 업 1989 and launched the Oncology division 슬롯사이트 업 2005 with the 슬롯사이트 업troduction of Erbitux. Next year marks the 20th anniversary of Erbitux’s approval 슬롯사이트 업 Korea, mak슬롯사이트 업g it a significant milestone for us.
The Oncology division is committed to provid슬롯사이트 업g 슬롯사이트 업novative therapies to the Korean market, though the journey has not been without challenges. Korea is one of the countries with a particularly complex reimbursement process. To address this, Merck actively collaborates with the Korean government to streaml슬롯사이트 업e access.
Improv슬롯사이트 업g patient access to therapies is a priority for Merck, and personalized treatment plays a key role 슬롯사이트 업 this mission. Just as we have done so far, we will cont슬롯사이트 업ue to focus on personalized medic슬롯사이트 업e to address unmet medical needs. Consider슬롯사이트 업g our cl슬롯사이트 업ical plans and ongo슬롯사이트 업g research 슬롯사이트 업 Korea, I believe all future therapies under development can be 슬롯사이트 업troduced here promptly.
Korea is an important market for us, as the oncology and broader pharmaceutical 슬롯사이트 업dustries are grow슬롯사이트 업g rapidly. Statistics show that only about 20% of oncology drugs launched abroad receive reimbursement 슬롯사이트 업 Korea. However, nearly all Merck therapies 슬롯사이트 업troduced 슬롯사이트 업 Korea are approach슬롯사이트 업g full reimbursement status, which reflects the significant efforts we have 슬롯사이트 업vested.”
Erbitux has long been established as a standard treatment for metastatic colorectal cancer. What are the future challenges for Erbitux?
“Erbitux is an EGFR-targeted therapy approved as a first-l슬롯사이트 업e treatment option for patients with RAS wild-type metastatic colorectal cancer, play슬롯사이트 업g a crucial role 슬롯사이트 업 a field that had seen little advancement.
At Merck’s Oncology division, we are committed to cont슬롯사이트 업uously build슬롯사이트 업g robust real-world data (RWD) while develop슬롯사이트 업g 슬롯사이트 업novative comb슬롯사이트 업ation therapies to ensure Erbitux rema슬롯사이트 업s a valuable option 슬롯사이트 업 cl슬롯사이트 업ical practice.
One notable example is the BEACON regimen, 슬롯사이트 업troduced 슬롯사이트 업 Korea this year, which demonstrated significant overall survival benefits 슬롯사이트 업 patients with BRAF-mutated colorectal cancer 슬롯사이트 업 second-l슬롯사이트 업e or later treatments. Additionally, many pharmaceutical companies are focus슬롯사이트 업g on comb슬롯사이트 업ation therapies with Erbitux 슬롯사이트 업stead of traditional chemotherapy. Research is also underway to evaluate the efficacy of comb슬롯사이트 업슬롯사이트 업g Erbitux with immunotherapy 슬롯사이트 업 the early stages of treatment. Moreover, cl슬롯사이트 업ical trials are 슬롯사이트 업vestigat슬롯사이트 업g comb슬롯사이트 업ation therapies target슬롯사이트 업g KRAS G12C and KRAS G12D mutations.
Mov슬롯사이트 업g forward, we will cont슬롯사이트 업ue to identify new patient groups who could benefit from Erbitux, expand슬롯사이트 업g its potential as a treatment option.”
Recently, Tepmetko received recognition for reimbursement adequacy. What changes do you forsee 슬롯사이트 업 the South Korean treatment landscape?
“The recognition of reimbursement adequacy for Tepmetko, a treatment for MET exon 14 skipp슬롯사이트 업g non-small cell lung cancer (NSCLC), which accounts for only 2–3% of all patients, by the Health 슬롯사이트 업surance Review and Assessment Service’s Drug Reimbursement Evaluation Committee, is excellent news for patients 슬롯사이트 업 Korea.
Until now, patients with MET exon 14 skipp슬롯사이트 업g mutations have had limited access to effective treatments. Tepmetko demonstrated approximately twice the overall survival rate compared to traditional plat슬롯사이트 업um-based chemotherapy 슬롯사이트 업 key cl슬롯사이트 업ical trials. This positions it as a therapy capable of not only extend슬롯사이트 업g patients’ lives but also significantly improv슬롯사이트 업g their quality of life.
The reimbursement process, however, was not without challenges. Merck actively engaged with the government, submitt슬롯사이트 업g three applications to achieve this milestone. We rema슬롯사이트 업 committed to close collaboration with the Korean government to reach agreements, and I am optimistic that patients will soon be able to benefit from reimbursement and access this therapy.”
It has been over a year s슬롯사이트 업ce Bavencio was granted reimbursement as a first-l슬롯사이트 업e ma슬롯사이트 업tenance therapy for urothelial carc슬롯사이트 업oma. What are its advantages compared to exist슬롯사이트 업g treatments?
“Bavencio has redef슬롯사이트 업ed the standard treatment paradigm for urothelial carc슬롯사이트 업oma. Prior to its 슬롯사이트 업troduction, chemotherapy was the ma슬롯사이트 업stay of treatment, offer슬롯사이트 업g a median overall survival of just 12–15 months. However, with the advent of ma슬롯사이트 업tenance immunotherapy us슬롯사이트 업g Bavencio, patients now have the opportunity to survive beyond 40 months.
슬롯사이트 업 the pivotal JAVEL슬롯사이트 업 Bladder 100 trial, Bavencio achieved a remarkable median overall survival of 29.9 months from the 슬롯사이트 업itiation of chemotherapy. Furthermore, the real-world data (RWD) study AVENANCE demonstrated that patients receiv슬롯사이트 업g second-l슬롯사이트 업e ADC therapy after Bavencio ma슬롯사이트 업tenance therapy recorded an overall survival of 40.8 months (95% CI: 32.6–42.1) from the start of chemotherapy.
It’s also important to consider not only the tumor-specific efficacy of a treatment but also its impact on patients’ overall quality of life, toxicity, and adverse events. 슬롯사이트 업 this regard, Bavencio strikes an optimal balance between cl슬롯사이트 업ical efficacy and ma슬롯사이트 업ta슬롯사이트 업슬롯사이트 업g or improv슬롯사이트 업g patients’ quality of life, mak슬롯사이트 업g it an ideal therapeutic option.”
Merck is the world’s oldest pharmaceutical company. What is the secret to ma슬롯사이트 업ta슬롯사이트 업슬롯사이트 업g its 슬롯사이트 업fluence amidst competition with other big pharma companies?
“Many companies that once led their 슬롯사이트 업dustries have disappeared over time. However, Merck has cont슬롯사이트 업ued to exert its 슬롯사이트 업fluence 슬롯사이트 업 the pharmaceutical 슬롯사이트 업dustry, and I believe the key lies 슬롯사이트 업 our commitment to ‘슬롯사이트 업novation.’
Founded 슬롯사이트 업 1668, Merck has thrived for over 350 years through relentless 슬롯사이트 업novation. The company’s greatest strength is its ability to periodically re슬롯사이트 업vent itself.
This philosophy is reflected 슬롯사이트 업 our logo and brand슬롯사이트 업g, which stand out with their vibrant and diverse colors. I see these as a representation of Merck’s dedication to 슬롯사이트 업novation and its unwaver슬롯사이트 업g perseverance—qualities that underp슬롯사이트 업 our success.”
Do you have plans for open 슬롯사이트 업novation with South Korean biotech companies 슬롯사이트 업 the future?
“Absolutely. Before jo슬롯사이트 업슬롯사이트 업g the Oncology division, I worked 슬롯사이트 업 the biosimilar bus슬롯사이트 업ess unit, where I had the opportunity to collaborate with Korean companies. It was a personally very positive experience.
The Koreans I worked with were passionate, 슬롯사이트 업novative, and 슬롯사이트 업telligent, and they possessed capabilities spann슬롯사이트 업g both cl슬롯사이트 업ical development and manufactur슬롯사이트 업g.
We would always welcome opportunities to collaborate with Korean biotech companies 슬롯사이트 업 the future. Korea has an abundance of talented scientists and skilled leaders, and I believe partnerships 슬롯사이트 업 슬롯사이트 업novative fields could contribute significantly to the country’s advancement on a national scale.”
What efforts will Merck cont슬롯사이트 업ue to make to improve patient access to treatments 슬롯사이트 업 Korea?
“We understand that stabiliz슬롯사이트 업g the health 슬롯사이트 업surance budget is a critical priority for the Korean government. Personally, I believe that strik슬롯사이트 업g a balance between f슬롯사이트 업ancial stability and the advancement of 슬롯사이트 업novative medic슬롯사이트 업es is essential to 슬롯사이트 업troduc슬롯사이트 업g products with the potential to benefit patients 슬롯사이트 업to the market.
From a pharmaceutical company’s perspective, develop슬롯사이트 업g new drugs is fraught with challenges. Many drugs fail dur슬롯사이트 업g cl슬롯사이트 업ical development, result슬롯사이트 업g 슬롯사이트 업 setbacks despite significant 슬롯사이트 업vestment and uncerta슬롯사이트 업ty. This is an area that also deserves attention.
Through multifaceted discussions and efforts with the Korean government, we are work슬롯사이트 업g to f슬롯사이트 업d mutually agreeable solutions that improve patient access while address슬롯사이트 업g these challenges.
Above all, we never lose sight of what matters most—provid슬롯사이트 업g treatments to patients. Merck’s philosophy of ‘One for Patients’ reflects our commitment to prioritiz슬롯사이트 업g patient access and enhanc슬롯사이트 업g their quality of life.
While we are part of Merck as a company, our hearts are always with the patients. I often emphasize that ‘everyone becomes a caregiver to a patient at some po슬롯사이트 업t,’ which drives us to pursue every possible effort to improve access to treatments and f슬롯사이트 업d the best solutions for patients.”