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Ansis Helmanis is a former FDA official and founder of RegLink Associates.

ISPOR's Value Assessment Stakeholder Conference showed its Special Task Force still reaching for clarification around the subject, writes Ansis Helmanis.

ISPOR Task Force Grapples with Value Questions

Harvey Bale, Jr., MD, former Director-General, IFPMA

IP: Securing a Global Consensus—Can Industry Do It Again?

Jane Henney: Lessons from the FDA Front Line

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

Stacey Fung, Head of Global Medical Information at Gilead Lifesciences, delves into the evolving role of Medical Information (MI) in the pharmaceutical industry. Covering key topics like patient engagement through omnichannel strategies, combating misinformation, and leveraging AI to enhance medical inquiries, the conversation with Stacey highlights MI's critical role in ensuring patient safety and supporting drug development. She also shares her professional journey and tidbits for early career professionals on professional development.

The Transformative Role of Medical Information in Customer Engagement

Traci Miller (Director, Sonexus™ Access and Patient Support, Cardinal Health) discusses current digital trends in the patient services industry, as well as how the optimal balance of technology and talent can transform manufacturer-sponsored patient support programs. Cardinal Health combines best-in-class program and pharmacy operations with smart digital tools to ensure product and patient success and reduce operational costs.

Using Technology and Talent to Unlock Value and Cost Savings in Patient Services

Traci Miller, Director, Sonexus™ Access and Patient Support, Cardinal Health, discusses the current digital trends in the patient services industry and how the optimal balance of technology and talent can transform manufacturer-sponsored patient support programs. Hear how Cardinal Health combines best-in-class program and pharmacy operations with smart digital tools to ensure product and patient success and reduce operational costs. 

Unlocking value and cost savings in patient services with technology and talent 

Elyse Blazevich

Colorado has emerged as a thriving hub for life sciences innovation, with over 720 companies spanning sectors like medical devices, diagnostics, biotech, and pharmaceuticals. In this interview with 

, Elyse Blazevich, the CEO and President of the Colorado Bioscience Association, provides a glimpse into the day-to-day operations of the organization, which is dedicated to championing the life sciences industry across the state. Blazevich discusses the association's multifaceted approach, from facilitating access to capital and partnerships to hosting educational and networking events, as well as its work in cultivating a diverse talent pipeline and advocating for the industry at the state and federal levels.

00:23 - Blazevich's background and journey to becoming involved with the Colorado Bioscience Association

02:32 - Day-to-day operations of the Colorado Bioscience Association

03:49 - Overview of the Colorado life sciences market, including key sectors and statistics

05:15 - Talent pipeline and recruitment in Colorado

06:11 - Colorado life sciences incubation program

07:35 - Fundraising trends and advice for Colorado life sciences companies

09:41 - Role of artificial intelligence and machine learning in the life sciences ecosystem

Elyse Blazevich discusses the Colorado Bioscience Association’s efforts to support the state’s life sciences sector by fostering partnerships, advocating for industry growth, and building a diverse talent pipeline.

Elyse Blazevich on Driving Innovation in Colorado's Thriving Life Sciences Ecosystem

Long-term follow-up data from the Phase II PHAROS trial found that Pfizer’s Braftovi (encorafenib) in combination with Mektovi (binimetinib) produced sustained efficacy in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). The findings, which were presented at the ESMO Congress 2024, position the combination as a promising first-line therapy for this type of cancer, according to the trial investigators.

“BRAF V600E-mutant metastatic non-small cell lung cancer tends to be aggressive, and effective targeted first-line treatment options with manageable safety profiles are critical for the thousands of people who are diagnosed globally each year,” said PHAROS investigator Gregory Riely, MD, PhD, vice chair, clinical research, Department of Medicine, Memorial Sloan Kettering Cancer Center, in a press release. “The longer-term follow-up results from the PHAROS trial represent an important step forward in the treatment of BRAF V600E-mutant metastatic NSCLC, especially for treatment-naïve patients. These compelling results support the Braftovi plus Mektovi combination as a standard of care option for these patients.”

The open-label, multicenter, single arm PHAROS study examined Braftovi plus Mektovi combination therapy in treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC. The primary endpoint of the study was a notable objective response rate (ORR), while the secondary endpoint was duration of response (DoR).

Results demonstrated an ORR of 75% in treatment-naïve patients. Additionally, the median DoR was 40 months and median progression-free survival (PFS) reached 30.2 months. In previously treated patients, ORR was 46%, with a DoR of 16.7 months and PFS of 9.3 months.

The safety profile of Braftovi plus Mektovi was consistent with previous findings and no new safety signals were identified. Treatment-related adverse events (TRAEs) resulted in dose reductions for 26% of patients and treatment discontinuation for 16% of patients. Common TRAEs included nausea, diarrhea, and fatigue. Pfizer warns that new primary malignancies, cutaneous and non-cutaneous, can occur during treatment with this combination. Further, uveitis, hemorrhages, hepatotoxicity, cardiomyopathy, and embryo-fetal toxicity have occurred in patients treated with Braftovi plus Mektovi.

Previously, Braftovi plus Mektovi was approved by the FDA in October 2023, and by the European Commission in August 2024, for the treatment of BRAF V600E-mutant metastatic NSCLC. According to Pfizer, it maintains exclusive rights to the treatment in the United States, Canada, and all countries in Latin America, Africa, and the Middle East. Ono Pharmaceutical hold commercialization and for both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre Laboratories has exclusive rights in all other countries, including Europe and the Asia-Pacific region.

“These potentially practice-changing results from the PHAROS trial show that the combination of Braftovi plus Mektovi is providing long-term compelling efficacy for patients, and although no definitive conclusions can be made across trials, the duration of response and progression-free survival in treatment naïve patients appear to be the longest observed for BRAF V600E–mutant metastatic NSCLC compared with historical outcomes,” said Roger Dansey, MD, chief development officer, oncology, Pfizer, in the press release. “These latest data reflect our deep understanding of the science behind biomarker-driven cancers and add to our legacy in developing innovative targeted treatments in NSCLC. We are continuing to build upon this strong foundation with a pipeline of targeted medicines and combinations across our tumor areas of focus, including the ongoing investigation of Braftovi in earlier settings of metastatic colorectal cancer, and the exploration of a next-generation brain-penetrant BRAF inhibitor.”

1. Pfizer’s BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer. 

September 14, 2024. Accessed September 17, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-braftovir-mektovir-shows-long-term-clinically

Results from the Phase II PHAROS trial found that treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer administered Braftovi in combination with Mektovi achieved an objective response rate of 75%. 

Ansis Helmanis

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