J&J’s growth strategy in lung cancer draws on experience in multiple myeloma

Johnson & Johnson currently has one of the largest lineups in a variety of myeloma products. Since the drug gave its first FDA approval for this type of blood cancer a decade ago, the drug giant has expanded additional drugs in the space, representing a different approach. For Joshua Bauml, vice president of J&J lung cancer district stronghold, the company’s experience in multiple myeloma is a blueprint for its strategy in lung cancer.

“Look at what we do in multiple myeloma,” Baumer said. “We started an area where there was nothing, and we really built a pipeline. That’s exactly what we were going to do in lung cancer.”

J&J’s multiple myeloma combination is anchored by Darzalex. Today, the drug is not only J&J’s best-selling cancer product, but the company’s overall drug. J&J also has sensational expectations for its lung cancer drug Rybrevant. Lung cancer is one of the key areas of J&J, which is called the “disease stronghold.” In an interview at the annual meeting of the American Society of Clinical Oncology in Chicago, Baum developed J&J’s Rybrevant strategy.

Certain cases of lung cancer are driven by mutations in proteins called EGFR. Bauml, who considers lung cancer patients as clinicians for about 10 years, said lung cancer with EGFR mutations tends to develop in people with little history of tobacco exposure. Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancers; EGFR-mutated cancers account for 15% to 30% of these cancers. The high end of this range is Asia.

Targeted therapies can be used to address EGFR. Astrazeneca’s top cancer product, Tagrisso, had revenue of about $6.6 billion last year, a drug. This oral small molecule is designed to block enzymes that promote cancer growth and has become a standard therapy for some patients with EGFR mutations. However, one problem with these drugs is that when the cancer mutates, it becomes resistant to the drug.

J&J’s rybrevant is a bispecific antibody that provides two mechanisms of action. In addition to blocking EGFR, it also blocks a second receptor called MET. Two receptors are overexpressed on the surface of cancer cells. If the cancer mutates around EGFR, Rybrevant’s activity on MET targets can still resolve the cancer. The two targets are designed to prevent drug resistance. Rybrevant received accelerated FDA approval in 2021, a second-line treatment for exon 20 insertion mutation-driven NSCLC of EGFR. In March 2024, the FDA approved Rybrevant as a first-line treatment for such cancers, and the decision also translated the status of the drug into full approval.

Last August, the FDA approved another J&J drug, Lazertinib (Lazcluze), as the first-line treatment for EGFR-mutated NSCLC. Lazcluze also blocks EGFR, but as an oral small molecule, it passes through the cell membrane and binds to the target from the inside of the cell, Bauml said. The drug has been approved for use with Rybrevant.

“They will prevent resistance before resistance occurs,” Bauml said of both drugs. “If you mess up the constraints of rybrevant on the top,” he said. [of the cell]I still have my heart. The whole idea is that this dual approach allows for more activity. ”

There are more ways Rybrevant works. The tail end of the bispecific antibody is called the FC region, which interacts with the immune system. Bauml said Rybrevant’s FC region has been optimized to recruit immune cells. Although it is difficult to show this effect in humans, in laboratory tests, exposure to the drug leads to immune cell activity against them, Baumer said.

J&J multiple myeloma combination spans antibodies (Darzalex), bispecific T cell Endagers (Talvey and Tecvayli), and cell therapy (Carvykti). J&J actually borrowed from multiple myeloma to transplant its lung cancer pipeline. Baumer said the company explores Talvey and Tecvayli in lung cancer. Other types of drugs the company researches for lung cancer include small molecules and radiotherapy.

“I don’t need to limit myself to either way because of the expertise we have on J&J,” Baumer said. “Actually, all I can do is let us find the best target and then we figure out that way. Is it ADC (antibody drug conjugate)? Is it a radiotherapy? Is it bispecific?”

J&J expects Rybrevant to have a peak revenue of $5 billion. There is still a long way to go. Rybrevant and Lazcluze earned $141 million in the first quarter of 2025, up from $47 million in the same period last year. This is the first time the company has broken specific financial data on treatment.

Rybrevant’s growth may occur in different ways. As a bispecific antibody, the drug is used as an infusion and takes between 2 and 5 hours. The subcutaneous version of the drug takes only five minutes, making it easier for the patient. At last year’s ASCO meeting, J&J reported the results of the third phase, showing that subcutaneous Rybrevant not only roughly comparable to the intravenous formula, but actually led to an increase in overall survival. But last December, the FDA rejected the version of the drug, citing problems with manufacturing plants. There are no concerns raised about the safety or efficacy of the drug, Baumer notes that this injectable version of Rybrevant is available in Europe. He added that the company is committed to bringing injectable Rybrevant to patients in the United States as soon as possible.

The additional growth of Rybrevant may come from outside lung cancer. Bauml notes that EGFR and MET are associated with other malignant tumors. A phase 1/2 study is evaluating rybrevant in head and neck cancer. Bauml is expected to present the data at future scientific conferences. Colorectal cancer is another opportunity. At the European Society of Medical Oncology Annual Meeting last year, J&J provided data from an open-label Phase 1B/2 study to 43 patients with metastatic colorectal cancer that evaluated Rybrevant as well as standard chemotherapy. The results show that J&J drugs result in a total response rate of 49%. Baumer notes that metastatic colorectal cancer is usually incurable. But among the nine participants, the tumor became small and responded very well to treatment, so patients were able to stand out from the study because they were eligible for therapeutic surgery.

“So, the impact of Rybrevant is actually just beginning,” Bauml said. “We are very excited about the data we proved.” [the] Mariposa [study with Lazcluze]but we think the best is yet to come. ”

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